Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I continue the list of ways that your quality system can undermine your product teams (part 2 of 2)
Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I describe some common ways that your quality system can undermine your product teams (part 1 of 2).
Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully …
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.
Aaron is excellent to work with and has been invaluable for the team’s success. His consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on to streamline technical or regulatory …
“One approach to satisfy two sets of rules” for FDA software guidances As stated in the last blog post, there are two sets of rules for FDA software guidances—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard, which is easier to understand, and then …
FDA Software Guidances and the IEC 62304 Software Standard Read More »
“Agile” consists of a philosophy as well as multiple methods. The most well-known method and what most people associate with agile is the highly iterative scrum method, where scrum teams operate in 2-4 week sprints with daily meetings (scrums). Other agile methods are test-driven development, continuous integration, automated unit testing, planning poker, and pair programming. …
Challenges Adopting Agile Methods for Medical Device Software Read More »
Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers. That’s why I created this “map” of document interdependencies. It’s a way to help explain graphically how the many documents fit together for a new product. Some key points in the map are: Risk analysis …
Medical device product development involves many design and testing challenges. It also involves the challenge of documentation—writing and managing hundreds or thousands of pages of compliance documentation. The traditional approach to this documentation challenge is to manage the product documentation simply as a set of documents, usually Microsoft Word or Excel files. Figure 1 illustrates …
Don’t Rely on Documents to Manage Your Documentation Read More »
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