Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Vaccines with Multiple Doses

Vaccines with Multiple Doses

COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have ...
FDA Guidance Documents

FDA Guidance Documents

If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in ...
Article 59 Under the EU MDR

Article 59 Under the EU MDR

The EU regulators delayed implementation of the EU MDR by a year with its new date of application now being May ...
Optimizing CAPAs in the Medical Device Industry

Optimizing CAPAs in the Medical Device Industry

In this whitepaper, we will explore how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”. This paper will also discuss the purpose and basic principles of CAPAs, as well as how the process has developed over time.

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