R&Q's Blog

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

 

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us.


Challenge

Investigating acquired products and associated FDA clearances.

A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.

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.

Lists by Topic

see all