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.

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation 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 are available. Questions on supplier quality remediation? Contact us.


Challenge

The FDA found that not following your procedure is a problem.

A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (2CF820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

About R&Q's Case Studies: We hope this 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 are available.

Questions? Contact us.


Challenge

The FDA found problems you didn't think were there.

A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.

Introducing Our First In A Series of New R&Q Case Studies: Design History File Remediation

About R&Q's Case Studies: Our goal in producing case studies is to succinctly demonstrate how R&Q applied our unique expertise to tackle a client's challenge, implement a competent solution, and demonstrate real results. We will post each case study to our blog and offer a downloadable PDF as well, perfect for printing and/or emailing to colleagues and industry peers.

Our first case study focuses on Design History File Remediation and we hope you enjoy it. The content of future case studies will be around the services R&Q offers, including areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance - particularly remediation. Subscribing to our blog is the best way to know when future case studies are available. View all of our available Case Studies.

Regulatory Intel - Jan. 14, 2013 Quick-Hits

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:

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