R&Q's Blog

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

 

Clarifying the Clinical Evaluation Requirements: A Case Study

About R&Q's Case Studies: We hope this Clinical Evaluation Report 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

Design changes and MEDDEV 2.7/1 rev 4 compliance.

The client was implementing multiple design changes on a Class III implantable heart transplant device that required a submission to the Notified Body. As part of this submission, the Clinical Evaluation format needed to be updated to provide clarity and comply with MEDDEV 2.7/1 rev 4. The Notified Body provided feedback on the prior clinical evaluation reports and the client needed assistance in interpreting and addressing the feedback. The primary roadblocks / challenges were interpreting the information provided by the client, identifying and requesting any missing or insufficient documentation, and ensuring the information was comprehensive and understandable to the Notified Body once included in the Clinical Evaluation Report.

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.

Process Validation Case Study: Know What You Know... and What You Don't

About R&Q case studies: We hope this process validation case study helps you understand how we serve our medical device clients in this area. If you have specific process validation questions please contact us and we'll be happy to help. Looking to solve a different problem? Here are all of our available case studies. Subscribing to our blog is the best way to know when future case studies are available.


Challenge

Transfer troubles.

A company executed site transfer and design transfer together for a newly developed product without an in-depth understanding of the product and its manufacturing process. The lack of detailed product specifications, in-depth process design, and full process validation left the program team searching for a baseline to deem the product as acceptable once the design and equipment was transferred to its new location. The result? The program experienced setbacks in implementation and found itself handling a larger-than-ideal number of nonconforming lots.

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.

FDA Approved: A Human Factors and Usability Case Study

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FDA Approved: Creating and Implementing a Compliant Usability Engineering Process



Challenge

PMA supplement for usability updates not approved.

A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.

 

Challenge

High volume of data... and differing opinions.

A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.

5 Heads are Better Than 1: De-Risking Your Regulatory Pathway Using a Team Approach - A Case Study

About R&Q's Case Studies: We hope you find value in our second case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.

 

Challenge

Regulation doesn't have to be a barrier to innovation.

A client was developing a software package using Big Data to provide clinical decision support for physicians. They initially believed a premarket approval (PMA) could be required for the product depending on the claims that would be made. They were also concerned about the potential cost of clinical trials and the overall timing of bringing the product to market.

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.

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