R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Mergers and Acquisitions: The Devil Is In the Details - A Quality Management System (QMS) Integration Case Study

About R&Q's Case Studies: We hope you enjoy our fourth case study. All of our available case studies can be seen here. Subscribing to our blog is the best way to know when future case studies are available.

 

Challenge

So many companies, so many quality systems.

Medical device companies that are merging with or acquiring companies will often be left with quality systems that have conflicting requirements, or don't align with the parent company's quality system. It's also possible that one of the quality systems may not be compliant with the FDA Quality System Regulation, EU ISO 13485, and others. In R&Q's experience with warning letters and consent decrees, it's often the lack of assessment and alignment of quality systems that results in major discrepancies, often leading to warning letters and if not quickly corrected, consent decrees.

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