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©2018 by MBC & Affiliates, Inc.

October 21, 2019


                  FDA QSR-ISO Merge -  Is it Good for You?

     Today, we continue our discus...

October 10, 2019

     The US FDA made an official announcement (FDA Update in December 2018) that they intend to “supplant the existing requirements with … ISO 13485:2016.”  According to the FDA, they are taking these steps in order “to harmonize and modernize the Qualit...

October 1, 2019

                                          Why US?

Our clients love us...

September 23, 2019

Who’s in the driver’s seat of your medical device supply chain? You? The FDA? Other regulatory authorities?  Industry executives are bending over backwards to meet strict regulatory, safety, and quality system requirements, to navigate ever changing submissions process...

September 17, 2019

Here are 5 steps you can take to help you stay on track and focused.

September 10, 2019

This blog explores 21 CFR Part 11 and breaks down the differences between system access, audit trails, and electronic signatures.

September 3, 2019

Here's 3 tips for making sure your organization's training program will stack up to regulatory authority scrutiny.

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