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MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

Article overviews of the new MEDDEV 2.7/1 rev 4 for clinical evaluation of medical devices, including a quality plan to comply with the new revision.

MEDDEV 271 rev 4 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

What’s new in MEDDEV 2.7/1 rev 4 for clinical evaluations?

The third and fourth revision both give manufacturers three choices: 1) a clinical literature review, 2) performing a clinical study, and 3) a combination of literature review and performing a clinical study. However, the fourth revision is completely re-written, the fourth edition is 19 pages longer and it is now much harder to use the “literature only” route. The fourth revision includes stringent requirements for demonstrating equivalence between another device and your device. Therefore, many companies are now struggling to update their clinical evaluation reports to satisfy this new guidance document.

Overview of the content in MEDDEV 2.7/1 rev 4

The third and fourth revisions of the guidance both have a 5-stage process for clinical evaluations, but in the third revision only articulated stages 1 through 3 as stages leading up to writing a clinical evaluation report. The figure in section 6.3 of revision 4 now identifies a planning Stage 0 and the writing of the clinical evaluation report is referred to as Stage 4. Therefore, there is a lot more detail describing the planning and report writing stages than there was in revision 3. In addition, Stage 2 (Appraisal of clinical data) has been expanded from a single page to eight pages.

Based upon the above changes, you can infer that Competent Authorities have been unsatisfied with the quality of clinical data being provided to support the essential requirements for safety and performance. In turn, Notified Bodies are expected to be much more critical of the data presented and more guidance is provided to manufacturers. There is also much more guidance and more examples provided in the appendices, while the 12-page clinical evaluation checklist that was provided in revision 3 has been replaced by one page of bulleted items for Notified Bodies to consider.

Demonstration of equivalence

It is no longer sufficient to list several devices that are similar to your device and include those devices in your search of clinical literature. Now you may only select one device for equivalence. You must also provide a thorough analysis of equivalence with that device on the basis of clinical, technical and biological characteristics. This comparison includes providing drawings or pictures to compare the size, shape and elements of contact with the body.

Updating clinical evaluations

The new European Medical Device Regulations (EMDR) is expected to specify minimum requirements regarding the frequency of updating clinical evaluations, but MEDDEV 2.7/1 rev 4 discusses this in section 6.2.3. The frequency of updating your clinical evaluations must be justified and documented. Many considerations for this justification are discussed, but the end of that section indicates that devices with significant risks (e.g., implants) require at least annual updates to the clinical evaluation report. For devices with non-significant risks, and where the device is well established (e.g., a long clinical history), 2-5 years is the range of possible frequency. Longer than 5 years is not allowed.

Who should perform clinical evaluations?

Many device manufacturers are receiving nonconformities, because the evaluators are not sufficiently qualified or the qualifications are not documented. The qualifications must follow 6.4 of the new guidance and the qualifications set by your company should be documented in your procedure for clinical evaluations. You will need to document these qualifications with more than an abstract, but you will also need to present a declaration of interest for each evaluator. Evaluators need knowledge in clinical study design, biostatistics, information management, regulatory requirements and medical writing. Evaluators also need knowledge specific to the device, its technology and its application. Evaluators must also have a higher education degree in the field and 5 years of experience or 10 years of experience if they do not have a higher education degree. Due to the breadth and depth required of qualifications required, it may be necessary to assemble a team to perform evaluations.

Creating a quality plan for compliance with MEDDEV 2.7/1 rev 4

There are seven steps that need to be included in your quality plan for compliance with MEDDEV 2.7/1 rev 4:

  1. update your external standards to replace MEDDEV 2.7/1 rev 3 with MEDDEV 2.7/1 rev 4
  2. revise your procedure and associated templates for a literature review and clinical evaluation report to meet the requirements of MEDDEV 2.7/1 rev 4
  3. document the qualifications of evaluators for clinical evaluations
  4. document a plan/schedule for updating your clinical evaluation reports for each product family
  5. train evaluators, regulatory personnel and any applicable internal auditors on the requirements of MEDDEV 2.7/1 rev 4 and updated procedures and forms
  6. begin updating clinical evaluations according to your plan
  7. perform an internal audit of your clinical evaluation process

Learning more about MEDDEV 2.7/1 rev 4

If you are interested in learning more about this revised guidance document, please register for our live webinar on Friday, January 27 @ Noon EST by clicking on the button below.

Click Here 300x115 MEDDEV 2.7/1 rev 4: How will your clinical evaluation change?

Posted in: CE Marking, Clinical Studies & Post-Market Surveillance

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Class 1 Device Requires Clinical Evaluation Report (CER) too!

Article explains how to write a clinical evaluation report (CER) for CE Marking Class 1 medical devices when there is little or no clinical study literature available. The history behind this European CE Marking regulatory requirement is explained as well.

Clinical study for this  e1446901425122 Class 1 Device Requires Clinical Evaluation Report (CER) too!

In 2010 the European Medical Device Directive was updated to include many tougher regulatory requirements for medical devices of all types. One of this changes is criticized frequently by industry–the change to make essential requirement 14 to a general requirement for all devices. That requirement is now essential requirement 6a in Annex I of the current MDD (93/42/EEC as modified by 2007/47/EC). The general requirements are required for all devices–event products that do not require a Notified Body’s involvement.

Typical Search Strategy for a Class 1 Device

Class 1 devices do not typically have clinical studies performed for three reasons:

  1. the products are low in risk and therefore do not require clinical studies for regulatory approval
  2. the products have been on the market for a long time and therefore there is little innovation in these products
  3. clinical investigators are not interested in researching devices that have been used for a long time

Since there is typically no requirement for a clinical study for a Class 1 device, companies will perform a literature search in order to meet the requirements of Essential Requirement 6a. That search will typically result in articles that mention the device or a competitor device, but the device is typically just part of a clinical study that was performed for another device (i.e., the device of interest is merely an accessory). If there are clinical studies, the studies may be quite old and it may be more helpful to search for review articles first. In the end, you may end up finding no clinical studies for the type of device you are designing, but a clinical evaluation report is still required for CE Marking for Class 1 devices.

It may be painful for you and your company to conduct a clinical evaluation, even using the literature route, when there are no new clinical studies to find. However, the CE Marking regulations are written to address all devices and material innovations alone are driving the need for companies to reconsider the “state of the art” for even Class 1 devices. It is also important to consider emerging issues such as infection control with antibiotic resistant strains and the trend toward using disposable instruments such as drill bits.

Reference Articles for Clinical Evaluation Reports and PMS

I have published 3 previous blogs specifically on the topic of clinical studies and post-market surveillance over the past couple of years. Please click here if you are looking for more information on this topic.

Procedure/Template for Class 1 Device Clinical Evaluation Report (CER)

If you are looking for a procedure (SOP) and associated literature search protocol template for a clinical evaluation report (CER) please click here. The purpose of this 6-page procedure is to define the process for performing a clinical evaluation of literature in accordance with MEDDEV 2.7/1. There is also template provided for performing a literature search (i.e., TMP-004).

Posted in: Clinical Studies & Post-Market Surveillance

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Post-market surveillance plans: How to write one for CE Marking.

This article explains how to write a post-market surveillance plan for CE Marking and how to determine if a post-market clinical follow-up (PMCF) study is required.

Screenshot 2015 12 15 at 6.18.57 AM Post market surveillance plans: How to write one for CE Marking.

A post-market surveillance (PMS) plan is only required for the highest risk devices by the FDA (i.e., typically devices that require a PMA or premarket approval). For CE Marking, however, all product families are required to have evidence of post-market clinical follow-up (PMCF) studies or a justification for why PMCF is not required.

Why is a post-market surveillance plan a “hot button” with auditors recently?

Post-Market Surveillance is an area of emerging concern around the world. Not just a procedure for PMS, but an actual product-specific plan for gathering post-production data about your product or product family. Product registries, the anticipated launch of Eudamed and the implementation of UDI regulations are part of this industry-wide movement. The FDA has articulated the US plan for strengthening PMS in a guidance document, while the European PMS efforts are being debated as a central part of the new European Medical Device Regulations.

The biggest mistake I see 

The biggest mistake I see is that manufacturers refer to their PMS procedure as the PMS plan for their product family, and they say that they do not need to perform a PMCF study because the device is similar to several other devices on the market. Manufacturers need to have a PMS plan that is specific to a product or family of products.

How often is post-market surveillance data collected?

Your post-market surveillance procedure needs to be updated to identify the frequency and product-specific nature of post-market surveillance for each product family or a separate document needs to be created for each product family. For devices that are high-risk, implantable or devices that have innovative characteristics the manufacturer will need to perform some PMCF studies. Even products with clinical studies might require PMCF, because changes to the device, accessories and range of sizes may not be covered by the clinical studies. MEDDEV 2.12/2 provides guidance on the requirements for PMCF studies, but most companies manufacturing moderate risk devices do not have experience obtaining patient consent to access medical records in order to collect PMCF data–such as postoperative follow-up data.

Additional Resources

Medical Device Academy has created a post-market surveillance plan template that you can download for free. If you are looking for a procedure for post-market surveillance, please click here. If you are interested in learning more about PMS and PMCF studies, we also have a webinar on this topic.

Posted in: Clinical Studies & Post-Market Surveillance

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PMCF: Is a post-market clinical follow-up study required for CE Marking?

This article explains how to determine if your medical device requires a post-market clinical follow-up (PMCF) study for CE Marking. This is currently a non-existent requirement for most 510k submissions, but it is an area of emerging concern for all medical device regulations and this article explains why substantial equivalence is not enough.

F1.large  PMCF: Is a post market clinical follow up study required for CE Marking?

Why post-market clinical follow-up is an area of emerging concern.

For CE Marking applications of medical devices, all medical devices are required to have evidence of a post-market clinical follow-up (PMCF) study protocol or a justification for why a post-market clinical follow-up (PMCF) study is not required. The biggest mistakes I see are that manufacturers refer to their post-market surveillance (PMS) procedure as the post-market surveillance (PMS) plan for their product family, and they say that they do not need to perform a post-market clinical follow-up (PMCF) study because the device is similar to several other devices on the market (i.e., substantially equivalent).

Why Substantial Equivalence Isn’t Enough

This rationale fails the technical review of most CE Marking submissions, because although products can be approved for CE Marking based upon substantial equivalence, the manufacturer must continue to monitor the performance of the device after the product is launched to make sure of two critical things:

  1. Is the substantially equivalent device actually as safe and efficacious as the predicate device?
  2. Are there new risks that are identified when the device is used for a long duration (e.g., implanted), by a broader user population or to treat a broader patient population / broader indication for use?

A post-market clinical follow-up (PMCF) study MIGHT be needed

If you have a high-risk device that is implantable, has an innovative design and you are using moon rocks for the patient contacting materials you obviously need a post-market clinical follow-up (PMCF) study. If you make a generic version of sterile bandage with a cartoon character for decoration, you obviously don’t need a post-market clinical follow-up (PMCF) study. Unfortunately, most products fall into the “might be needed” category rather than a “yes” or “no.” If you have any experience in regulatory affairs, you know that regulators love guidance documents and systematic methods of evaluation. Here’s my systematic method of evaluation…

Step-by-Step Recommendations

Step 1 – Read MEDDEV 2.12/2.

Step 2 – Make a table with each of the 17 “might be needed” categories from the guidance document in the far left column.

Step 3 – In the second column, indicate whether the risk category from the table applies to your device–”yes” or “n/a.”

Step 4 – As with all good checklists, you need to explain your rationale for non-applicability wherever the category doesn’t apply. Enter your explanation in the third column next to the “n/a”…PS – nobody really cares if the “n/a” is capitalized.

Step 5 – If you typed “yes” in the second column, then you need to provide a cross-reference to the information in your technical file that explains how you address this risk. There are three places you can look: 1) your design requirements trace matrix (if you have one that looks like mine), 2) as a risk control in your risk analysis that you performed during the design process prior to “design freeze”, and 3) in your clinical evaluation report. Ideally, you can easily cross-reference to a section of your controlled document that is in outline format.

Note: Now you have another reason to make that document a controlled document with an outline format.

Step 6 – After you add a cross-reference to the risk control(s) in your table, now you need to indicate whether the risk controls are adequate or not. “Yes” is probably the answer only if you can cross-reference to a state-of-the-art guidance document or harmonized standard that has been implemented as a pre-market risk control to evaluate the  specific risk. For longevity of implants, usability by all intended users and patient satisfaction the tests are seldom adequate; while usability and patient selection often are only evaluated by clinical studies. If the tests and pre-market clinical studies are not adequate, then “No” is your your answer and you need to conduct a post-market clinical follow-up (PMCF) study in order to address that specific residual risk. 

Step 7 – If you indicate that your pre-market risk controls are adequate, then in your post-market surveillance plan you can indicate “no post-market clinical follow-up (PMCF) study required.” However, if you were unable to verify that your pre-market risk controls are adequate to address one of the 17 risk categories identified in MEDDEV 2.12/2, then you need to conduct a post-market clinical follow-up (PMCF) study.

When do existing products suddenly develop the need for a post-market clinical follow-up (PMCF) study?

Even products with pre-market clinical studies might require post-market clinical follow-up (PMCF), because changes to the device, accessories and range of sizes may not be covered by the clinical studies. Additionally, there are certain risks of implantable products that cannot be assessed during the normal duration of a clinical study (e.g., how long will an implant last). MEDDEV 2.12/2 provides guidance on the requirements for post-market clinical follow-up (PMCF) studies, but most companies manufacturing moderate risk devices do not have experience obtaining patient consent to access medical records in order to collect post-market clinical follow-up (PMCF) data–such as postoperative follow-up data. If you don’t have experience collecting this patient-specific data in a compliant way, you should consult a clinical research associate (CRA) or engage a clinical research organization (CRO). My procedure on clinical studies (SYS-009) explains some of the basics.

Additional Resources

I also wrote an article in BoneZone: “Post-Market Studies in Lieu of Clinical Studies”. This article emphasized the increasing need for clinical data for device approval and reimbursement, but it focused on using post-market clinical follow-up (PMCF) study data as an alternative to conducting a traditional, pre-market clinical study.

If you are looking for a procedure for post-market surveillance (PMS), please click here. If you are interested in learning more about post-market surveillance and post-market clinical follow-up (PMCF) studies, we also have a webinar on this topic. If you are looking for a clinical evaluation report (CER) procedure or literature search protocol template, please click here.

Posted in: Clinical Studies & Post-Market Surveillance

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Avoiding Clinical Evaluation Report (CER) Pitfalls

This article explains the key steps to preparing a successful clinical evaluation report (CER) for submission of a technical file for medical device CE Marking.

Photo for Clinical Evaluation Report Blog 1024x931 Avoiding Clinical Evaluation Report (CER) Pitfalls

Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Essential requirement 6a, the clinical evaluation report (CER), is required for all medical devices that are CE Marked. Up until the Medical Device Directive (MDD) was modified in 2010 (i.e., 2007/47/EC), only high-risk devices required a clinical evaluation report. After the MDD was modified, a CER was required for all medical devices–even Class I devices that do not require a Notified Body. To help manufacturers understand the expectations and comply with this requirement, a guidance document was released for clinical evaluations in December of 2009 (i..e., MEDDEV 2.7/1 rev 3). MEDDEV 2.7/1 indicates that are there are three options for preparing a clinical evaluation report:

  1. perform a clinical study and summarize the results,
  2. perform a literature search of clinical study articles, or
  3. a combination of the first two options.

Preparing clinical evaluations are tedious, but not necessarily challenging. I like to compare the preparation of clinical evaluation reports to bouldering problems. Once someone shows you the most efficient path, climbing the wall no longer seems so challenging.

Literature Search Protocol (TMP-004)

Section 6.1 of the guidance document indicates that a literature search protocol should be used to identify, select and collate clinical study articles for a literature search. Key elements of your search protocol should include: which search databases you selected and why, intended use and indications for use of the device, similar devices that are on the market and a comprehensive date range starting with the earliest clinical studies or the last date of a previous clinical evaluation. Your search protocol should specify inclusion and exclusion criteria, and you will need a systematic method for tracking your results.

I created a protocol template, TMP-004, which I use to perform clinical literature searches. The protocol includes suggested databases for literature sources, a list of adverse event databases and a database for clinical investigations that should be included in your search. The protocol also includes criteria for evaluating the results of the search. Evaluation criteria should include the type of clinical study, the number of patients, the study design, etc.

Qualified Individuals

In order to conduct a clinical evaluation, you need a cross-functional team–as you should have for all post-market surveillance and risk management activities. One of the team members should be an expert in design of the device or similar devices. Another person should be an expert in performing literature searches to ensure that the review of literature is comprehensive. Finally, the team needs at least one person with a clinical research perspective in order to critically evaluate the clinical data. The qualifications of these individuals should be described in an appendix of your clinical evaluation report, and typically this is done by providing a copy of each persons resume or curriculum vitae. Omission of these qualifications or the failure to rely upon clinical experts to perform a review of the data is a common nonconformity raised by technical reviewers from Notified Bodies.

Selection of Databases

When you are writing a literature search protocol, it is important to specify why you selected certain search databases and to ensure that you include more than one database. Each literature search database has different strengths and weaknesses. If you are not sure which databases to choose and why, this is an indication that you need assistance with literature search methodology. This is typically part of the process for teaching doctoral candidates how to prepare for writing their dissertation and therefore academic credentials of the individuals contributing to the post-market surveillance activities is relevant.

Selection of Key Words

Often certain key words are more common in the title of clinical study articles than others, and these key words can help narrow the number of literature search results dramatically. Therefore, it is recommended to perform some preliminary searches with different key words in order to get a sense of which terms will be the most efficient in helping you to identify the articles that meet your inclusion criteria. These terms can also be used to exclude large numbers of articles that are not relevant. For example, if there are a large number of porcine studies in the literature, you might exclude the term “porcine” to ensure that animal studies involving pigs are excluded from your search results.

Inclusion & Exclusion Criteria

Many times articles will mention a key word or the name of a device, but the device is only mentioned as an accessory in a study rather than being the focus of the study. If the article only mentions the device, but doesn’t include clinical data regarding its use, then the article should be excluded. Only human studies should be included in your results, and if there are a large number of published studies you may purposely choose to exclude articles with the terms “case study” that may only include one or two patients.

Addressing Risks

Your clinical evaluation report (CER) is intended to assess the safety of your device by identifying any potential risks that you may have overlooked in your risk analysis and to help you estimate the severity of harm and the probability of occurrence for those harms. It is recommended to perform a preliminary hazard identification and risk analysis prior to conducting the clinical evaluation in order to identify the most likely risks associated with the device. Each of these risks should be specifically mentioned in the clinical evaluation–even if the clinical study data does not identify the risk. If a specific risk is identified during your hazard identification with no clinical data to support safety of the device related to that risk, then it may be necessary to conduct a clinical study or a post-market clinical follow-up (PMCF) study to evaluate the risk further.

Review of Post-Market Surveillance

When your device is first submitted for CE Marking, you may not have any clinical history with the device and it is only possible to estimate risks. For this reason, it is important to include post-market surveillance information about similar products as an input to your clinical evaluation process. After your product is launched, you will have complaint handling data and adverse event data specific to your device. Therefore, you should periodically review the post-market surveillance data and compare it with the initial risk estimates. If the results are similar, then the risk analysis does not need to be updated immediately. If the post-market surveillance results are substantially different from your risk estimates, you should update your clinical evaluation report earlier than planned and update your risk analysis. i recommend stating this conclusion in each report summarizing post-market surveillance data–including a specific recommendation to maintain the current plan for the frequency of conducting clinical evaluations or a recommendation to change the schedule.

Appraisal of Clinical Literature

Your appraisal of clinical literature needs to be systematic and documented. Technical reviewers expect clinical data that supports and detracts from the conclusion that your device is safe and effective for the desired indications. Therefore, you should not exclude articles simply, because the findings are negative. You need to include appraisal criteria in your protocol to ensure that evaluation of literature search results is objective and systematic. I have included a recommended grading system for clinical study articles in my procedure for clinical evaluation reports (i.e., SYS-041). The graded results of each article identified is then summarized in the Appendices of the clinical evaluation report (CER).

Review and Update of Clinical Evaluation Reports (CERs)

Preparing a clinical evaluation report (CER) is time consuming, but the report is also a living document. Therefore, you need to have a post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report. This is why my literature search protocol includes adverse event databases.

Procedures & Templates

If you are looking for a procedure and literature search protocol for preparing a clinical evaluation report (CER), please click here. If you are interested in learning more about post-market surveillance and post-market clinical follow-up (PMCF) studies, we also have a webinar on this topic.

Photos shown in this article are two of my sons, Alex Beshay (13) and Bailey Packard (14), at this weekend’s bouldering competition at PETRA Cliffs in Burlington, VT. Every member of our family is an avid rock climber, including my 3-year-old daughter.

Posted in: CE Marking, Clinical Studies & Post-Market Surveillance

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New Release of TGA’s 2013 Assessment of Orthopaedic Implant Revision Rates

%name New Release of TGA’s 2013 Assessment of Orthopaedic Implant Revision Rates

October 1, 2013—Today, the Therapeutics Goods Administration (TGA) published their assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report.

This data will be extremely important to orthopedic companies as a recent source of post-market surveillance for their products and competitors, and development of Post-Market Clinical Follow-up (PMCF) study protocols.

You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.

2013 Annual Report

  • Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages

2013 Supplementary Reports

  1. Analysis of State and Territory Health Data All Arthroplasty – 19 pages
  2. Cement in Hip & Knee Arthroplasty – 15 pages
  3. Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
  4. Demographics and Outcome of Ankle Arthroplasty – 11 pages
  5. Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
  6. Demographics of Hip Arthroplasty – 28 pages
  7. Demographics of Knee Arthroplasty – 23 pages
  8. Demographics of Spinal Disc Arthroplasty – 11 pages
  9. Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
  10. Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
  11. Mortality following Primary Hip and Knee Replacement – 10 pages
  12. Revision of Hip & Knee Arthroplasty – 21 pages
  13. Unispacer Knee Arthroplasty – 6 pages
Post-Market Clinical Data

The requirement to conduct PMCF studies is not new. Release of MEDDEV 2.12/2 rev 2 (http://bit.ly/PMCFMEDDEV) in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex X, 1.1c of the Medical Device Directive (http://bit.ly/M5MDD).

Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster (www.linkedin.com/pub/hamish-forster/19/643/494), a Notified Body auditor for BSI, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.” You can find his paper on Orthoworld’s BoneZone website (http://bit.ly/BZPMCF).

If you are interested in reading more about the requirements for PMCF studies, you can also read the article that Dr. Dov Gal (http://bit.ly/DovGal) and I wrote for BoneZone (http://bit.ly/BZPMCFArticle) that was published on September 3, 2013.

Posted in: Clinical Studies & Post-Market Surveillance

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