Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

It’s 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All of a sudden you are jolted back to reality by an email about a serious incident at a French hospital involving your company’s heart monitor. Details are sketchy and somewhat lost in translation. It’s now 9:00 p.m. at your office in Europe. They are closed for the weekend and you can’t get more details. Can it wait until Monday? If you’ve been in your […]

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Does Your Medical Device Process Require Revalidation?

When you buy a new car you don’t expect it to run smoothly forever. Likewise, despite your diligence and best efforts, glitches will occur and process refinements will be made. Even new or modified processes falter after implementation. Thus, it’s important to remember that process validation is never complete for long. Process performance must be monitored and maintained over time to ensure consistent performance and full or partial revalidation of IQ, OQ, and PQ is simply part of the ongoing […]

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Understanding IQ, OQ and PQ for Medical Device Manufacturing Processes

The goal is process validation is to produce a stable medical device manufacturing process that offers consistent performance. Variation is minimal and predictable. Your Process Validation Plan (PVP) will provide the framework for executing three important phases in the validation process. Installation Qualification (IQ): Is everything installed correctly? Operational Qualification (OQ): Is everything operating correctly? Are operating limits understood? Performance Qualification (PQ): Did it produce the correct result? Is the process stable and capable?   This is the third post […]

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Putting Together a Solid Medical Device Process Validation Master Plan and Protocols

This is the second post in a 4-part blog series. In our first post we covered the basics of process validation, and in subsequent posts we cover IQ, OQ, PQ, and revalidation. Download the entire series in one convenient PDF. There are many ways to conduct process validation but given the huge variation in production volumes and manufacturing complexity, you won’t find many suggestions on how to go about it in FDA regulations or in ISO 13485. That being said, […]

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