Standard Operating Procedures (SOPs) for ISO 13485

The video provided below explains what is included when you purchase our standard operating procedures (SOPs) for ISO 13485:2016.

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Our turn-key quality management system for compliance with ISO 13485:2016 includes all of the standard operating procedures (SOPs) required by the standard and 21 CFR 820, 21 CFR 803 and 21 CFR 806 for the FDA. It also includes procedures for Canadian Medical Device Licensing and European CE Marking. In total we have 46 procedures (listed below). The standard operating procedures (SOPs) also have associated forms, logs and templates. We are also in the process of updating our procedures for Regulation (EU) 2017/745. In 2020, we will be updating procedures for compliance with Regulation (EU) 2017/746 for IVD devices.

In addition to procedures, forms, log sheets and templates; the quality management system includes a quality manual and pre-recorded training webinars. We also provide exams (i.e., 10-question quizzes) to verify training effectiveness. If you submit the completed exams to us by email in the native MS Word format, we will correct the exams and email you a training certificate with your corrected exams.

download 150x150 Standard Operating Procedures (SOPs) for ISO 13485
Turn-key Quality System (1 of 4 installments)

The turn-key quality system costs a total of $7,500, but we offer you the option to pay in four monthly installments of $1,875. If you would like to make other payment arrangements, please contact us @ rob@13485cert.com or +1.802.281.4381.

Price: $1,875.00

If you are thinking about purchasing standard operating rocedures (SOPs), instead of writing procedures yourself, it’s important to understand the intent of the author that wrote the procedures. Many buyers expect to “pay by the pound.” After writing hundreds of procedures, I found that it requires more work to write a short and effective procedure than a 50-page dust collector.

If a company has a mature quality management system, procedures tend to be lengthy, because each time an auditor finds a problem, another section is added to “clarify” the procedure. I try to write standard operating procedures that are concise and meet the requirements for an early-stage medical device company. Larger companies do not ask me to write many procedures. They ask me to audit procedures and to edit their procedures, but they seldom want me to start from scratch.

When Medical Device Academy writes standard operating procedures, we use a standard template for the sections. Almost everyone does this, but our template contains three unique elements:

  1. monitoring and measurement requirements for the process
  2. training and retraining requirements for personnel
  3. application of risk management

If you want to learn more about our procedure template, please read our blog about it:  http://bit.ly/12PartSOPTemplate. You can also search our blog archives for the term “SOP” or “procedure”.productHighlightsBanner Standard Operating Procedures (SOPs) for ISO 13485

  • Written specifically for early stage medical device companies
  • Create a ready made off-the-shelf Quality System for your company
  • Includes free updates for the ISO 13485:2016 as they become available
  • Can be used for FDA 483 responses
  • Are audit ready
  • Incorporates risk management into each procedure
  • Includes monitoring and measurement requirements for the process
  • Includes training and retraining requirements for personnel
  • Written by highly experienced industry subject matter experts

If you want to purchase individual procedures, or review what is included in a specific procedure, you can click on any of the hyperlinks provided below. If there is not a hyperlink, we will have one soon or we can review the content with you in a Zoom session.