Overview of Medical Device Process Validation and Regulatory Requirements

Before introducing a new medical device onto the market, manufacturers should have a high degree of certainty that their manufacturing processes have the proper controls in place to produce products that are safe and meet specified user, technical, and regulatory requirements. The US FDA and ISO 13485 require device makers to verify that their products meet documented design specifications, and this may be accomplished through post-production inspection or testing. This is otherwise known as “verifying” product quality and, if you […]

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All Topics, Process Validation

Understanding Medical Device Regulatory Training Requirements and Determining Who Needs to Know What

Who needs to be trained? What do they need to be trained on? Does everyone need to be trained on everything? How often do people need to be trained? All training and RA/QA managers need to ensure that their organizations meet FDA and international regulatory requirements for training. However, answering the questions above can present a challenge. Although the FDA regulations and ISO 13485:2016 require training, they do not prescribe training for specific roles. This makes many training managers wonder what […]

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Writing Medical Device Audit Reports That People Will Read – and Take Action On

Whether you are auditing a critical supplier for compliance with 21 CFR Part 820 or conducting an internal MDSAP audit for another facility within your company, the audit report is the most important output of your hard work. The audit report represents the who, what, why, and how of the audit…and your primary goal is to get people to take action. How you go about crafting that report will make a big difference in what action is taken on your […]

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All Topics, Auditing, ISO 13485:2016, Medical Device Quality Assurance

The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification

As of January 1, 2019, medical device companies selling in Canada had to be certified as compliant with the Medical Device Single Audit Program (MDSAP). Of course, MDSAP is not just about Canada, but it so happens that Health Canada was the first to make it mandatory. The other four MDSAP participants— Japan, Australia, Brazil, and the US —may follow suit. The challenges of preparing for your first MDSAP audit are substantial, but so are the long-term benefits. One audit […]

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All Topics, MDSAP
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