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Time to Take a Closer Look at FDA MDDS Moves
The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as [...]
FDA Lets MDDS Off The Regulatory Hook
FDA won't enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical ima [...]
FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers
Distilling the FDA Guidance on How to Address Inaccurate Online Claims Against Medical Device or Drug Manufacturers: If [...]
FDA Acts to Harmonize Global Adverse Event Reporting
FDA Acts to Harmonize Global Adverse Event Reporting - It's a small world after all. One of the by-products of globaliza [...]
Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer
This latest round of medical device warning letters is all about pushback. The FDA is not happy with the responses it re [...]
The Six C’s of Document Management Best Practices for Life Sciences
Implementing a best-practice solution for any quality process is essential to help an emerging Life Science company ensu [...]
