March 21-22, 2018 there is a two-day, Las Vegas 510k workshop for medical devices at the Embassy Suites Las Vegas.
The Las Vegas 510k Workshop begins at 9am, and registration begins at 8am. A networking lunch is included. Attendees receive a physical copy of the presentation slide deck, a hardcopy of the book “How to Prepare Your 510k in 100 Days,” and a flash drive with a complete set of 510k document templates. More important than what you receive, is what you will learn.
2-Day Las Vegas 510(k) Workshop 2018 – Wednesday, March 21 and Thursday, March 22.
Pre-workshop training on Biocompatibility & Electrical Safety
On March 20, the day before the 510(k) workshop, Nelson Labs will be offering a 1-day workshop on biocompatibility. The FDA guidance on bicompatibility that was released in 2016 has resulted in a lot of changes to what companies are required to submit for a 510(k) regarding biocompatibility. In addition, the ISO 10993-1, -17 and -18 standards are changing. Thor Rollins will explain this changes to you in his workshop. This is a critical workshop for anyone that has products which are CE Marked and will need to comply with the new versions of the standards or any companies with devices that require testing for contact duration longer than 30 days. Understanding the changes, will save your more than $10,000 in testing. Click on the button to register ($499).
Also on March 20, Eisner Safety will be offering a half-day workshop on updates to the IEC 60601-1. Leo Eisner is a world expert in electrical safety, and he will explain the current status of updates to the electrical safety requirements and the impact on your submission of a 510(k) or CE Marking application. This is a critical workshop for anyone that has products which are CE Marked and currently only compliant with edition 2.0 of IEC 60601-1 and any new device 510(k) or CE Marking submissions. Click on the button to register ($200).
Register for Las Vegas 510k workshop on March 21-22, 2018
We can also invoice you if you for the Las Vegas 510k workshop prefer or provide a receipt invoice for tax purposes. Just send an email to: firstname.lastname@example.org.
You can ONLY get the 510(k) book by attending Medical Device Academy’s Las Vegas 510k workshop or by purchasing the on-line 510k course.
Embassy Suites Las Vegas
4315 Swenson Street
Las Vegas, NV 89119
Sponsors for Las Vegas 510k Workshop
Medical Device Academy is a consulting firm that helps medical device companies with regulatory submissions, establishing new quality systems, internal/supplier auditing and training.
Eisner Safety Consultants is a network of experienced professionals which provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device companies with U.S., Canadian, European, and other international regulations. Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR), and training. For further details please see our complete list of services. All of our associates have more than 15 years of experience working in both international regulatory agencies and industry. This way we can provide answers to the regulatory issues, while meeting your business needs.
FDA eCopy is a service provided to device manufacturers and other regulatory consultants to help prepare, review, edit, print and ship FDA eCopy submisisons. We routinely prepare, review, edit, print and ship 510(k) submissions and pre-subs to the FDA with overnight FedEx shipping.
Factory-CRO is a global clinical research organization (CRO) that specializes in medical device and IVD clinical studies. The company manages clinical studies in Europe for CE marking and in the USA for FDA submissions. For more information, please download the company information sheet.
What you will learn in the Las Vegas 510k workshop
Rather than spend a little time on every aspect of a 510k submission, instead I will be focusing on the most important parts of a 510k submission with stories, examples and exercises. Our speakers will cover:
- How to select a predicate device – presented by Rob Packard
- How to write the indications for use (Section 4) – presented by Rob Packard
- How to create a testing plan – presented by Mary Vater
- How to manage your 510k project – presented by Mary Vater
- Biocompatibility (Section 15) – presented by Thor Rollins (to be confirmed)
- Software Validation (Section 16) – presented by Wolfgang Huber (to be confirmed)
- Electrical Safety & EMC Testing (Section 17) – presented by Leo Eisner
- Human Factors Testing (Sections 13 & 18) – presented by Adam Shames (to be confirmed)
- Clinical Study Testing (Section 20) – presented by Niels van Tienen
Niels van Tienen recorded a free webinar on the topic of clinical studies on Wednesday, August 9th, 2017.
Mary Vater recorded a free webinar on the topic of implementing risk management and design controls as part of your 510(k) project on Wednesday, August 16th, 2017.
Leo Eisner recorded a free webinar providing a status update on IEC 60601 Standards for Medical Electrical Equipment on August 23rd, 2017.
Rob Packard recorded a free webinar on how to create an FDA eCopy on August 30th, 2017.
Wolfgang Huber recorded a free webinar on Traceability Matrices for Software Validation on September 13th, 2017.
Nelson Labs has two on-demand webinars by Thor Rollins available on their website.
We will be collecting specific questions from registrants in advance to ensure that we include the areas that are most important to you. We have content from 24 webinars, covering each section of a 510k submission, and templates for each document. Therefore, we can review any section of a 510k in detail.
Click on the following hyperlink to download an information brochure for the Las Vegas 510k workshop.
Speaker biographies for the Las Vegas 510k workshop
Rob Packard is a regulatory consultant with ~25 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.
Niels is Director of Education and Training for Factory-CRO in the Netherlands. Factory-CRO’s clinical team organizes and supervises clinical investigations in Europe and the US, including a variety of medical writing activities for medical devices companies. Factory-CRO provides regulatory, clinical trial and clinical evaluation services. Niels is responsible for managing clinical study projects for medical device and IVD clients, and he has a Health Science Masters Degree from Maastricht University. He will be a guest speaker at the Amsterdam workshop sharing his Clinical Study Testing (Section 20) expertise. Niels also presented a free webinar on Medical Device Clinical Study Requirements on August 9, 2017.
Niels Van Tienen MSc – Director, Education and Training
Phone: +31 30 229 2727 (x171) | Cell: +31 6 52357492| Email: email@example.com
Prof. Bronkhorstlaan 10 Bld. 54 | 3723 MB Bilthoven | The Netherlands
Leo is the Principal Consultant of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, an expert in product safety for medical electrical devices (IEC 60601 series of standards), has been heavily involved in standards development focused on the IEC 60601 series of standards including working on IEC 60601-1, 3rd ed. + Amendment 2 (due out late 2019), has worked for several Notified Bodies as an auditor & technical reviewer, and is an expert in CE marking for the medical device directive. He has over 30 years experience in product safety, and he routinely speaks all over the world as an international expert on the topic of electrical safety and IEC 60601-1. During the Workshop Leo will be discussing Electrical Safety & EMC Testing (Section 17).
Phone: +1 503 244 6151 Cell: +1 503 709 8328 Email: firstname.lastname@example.org
3331 SW Seymour Street Portland OR, 97239
Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices and standalone software. She also has experience with CE Marking and Canadian Licensing application. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas. As a guest speaker, Mary is going to explain how design controls and risk management should be integrated with the process of your 510k preparation.
Mary Vater – Consultant for Medical Device Academy
Adam is a human factors expert. He has an M.B.A. in International Business from the Fox School of Business and Management at Temple University and a B.S. in Human Factors Engineering and Psychology (double major). From Tufts University. He has over a decade of extensive research experience, and has conducted hundreds of usability studies with thousands of participants around the world. He has also been the principal investigator on numerous successful IRB reviewed studies. As a guest speaker, Adam will be explaining how to design and conduct human factors studies for your 510k submission.
Adam Shames – Founder & CEO of Core human Factors, Inc.
Wolfgang Huber is Co-Founder of Matrix Requirement Medical. He is a software engineer that will be speaking on IEC 62304 and the requirements for software documentation in a 510k submission. His company developed a web-based application to help medical devices organize documentation (requirements, specifications, use cases, tests, risk analysis) for their Design History File (DHF). The software eliminates the need to exchange word documents, maintains version control and automatically creates a traceability matrix. The company website includes testimonials for customers that use the software for creating their 510k submission documents.
Wolfgang Huber – Co-Founder of Matrix Requirement Medical
Thor Rollins is Director of Toxicology and Extractables and Leachables (E&L) Consulting at Nelson Laboratories, LLC in Salt Lake City, Utah. He is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the Northern Cali Biomed ASQ group meeting in 2010 and 2012 as well as published articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.
Thor Rollins – Director, of Toxicology and Extractables and Leachables (E&L) Consulting Nelson Labs