Join Our Webinar: Effectively Implement ISO 14971:2019 & Maintain Your Risk File

Join internationally esteemed industry experts Audrey Prosser and Rebecca Waterbury as they discuss [...]

10 Years and Counting!

Exemplar Compliance Celebrates 10 Years     Exemplar Compliance, LLC [...]

By |2021-10-20T14:40:31+00:00October 14th, 2021|Company Updates, Technical Article|0 Comments

Supply Chain Management

Understanding Supply Chain Management   There is more to Supply [...]

U.S. FDA Pre-Approval Inspections (PAI)

If you have worked in this industry for at least a few years you have probably heard the phrase “PAI” thrown about.  What is a PAI? Why is it important? And how can I best position my company and our product?

FDA’s New Guidance for Medical Device Data System and Medical Image Storage

What's new for Medical Devices regulated by the U.S. FDA? Find out what you need to know regarding Medical Device Data Systems and Medical Image Storage.

By |2021-10-20T03:48:03+00:00October 8th, 2019|FDA Guidance, Technical Article|0 Comments

Quality Checklist: Keep Your Quality System On Track With These Simple Reminders

Keep your Quality System on track with these simple reminders. This fun end-of-year quality checklist can be done any time of the year.

By |2022-02-08T02:06:00+00:00May 12th, 2019|Quality Checklist, Technical Article|0 Comments

5 Tips To Improve Your Quality Budget

5 things that many companies forget to budget for when making their annual quality budget. Take a look at these items to make sure you have budgeted enough dollars to make sense!

Getting Ready For Quality Audits And FDA Inspections

What can I do to get ready for a quality audit or inspection by the U.S. FDA? Who do I need to prepare on my site? What do I do about known gaps in our systems? Read this article to learn more.

By |2022-03-07T16:50:33+00:00August 1st, 2017|Quality Checklist, Technical Article|0 Comments
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