RQM+ Medical Device and In Vitro Diagnostic Blog

Remediation | Fda | Case Studies | Clinical Evaluation Report | Medev 2.7/1

Clarifying the Clinical Evaluation Requirements: A Case Study

on 1 August 2017 | By Stephen Biernacki

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...
Read More
Remediation | Fda | 510(K) Review | 510(K) | Case Studies | Acquisitions

Acquisition Regulatory Assessments: A Case Study

on 25 January 2017 | By Stephen Biernacki

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...
Read More
Case Studies | Process Validation

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

on 13 December 2016 | By Stephen Biernacki

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?...
Read More
Warning Letter | Remediation | Fda | Supplier Quality | Case Studies

Revamping Supplier Quality: A Case Study

on 12 September 2016 | By Stephen Biernacki

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?...
Read More
Remediation | Fda | Case Studies | Capa | Capa Remediation

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

on 8 September 2016 | By Stephen Biernacki

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...
Read More
Usability | Fda | Human Factors | Pma Supplement | Pma | Case Studies | Iec 62366

FDA Approved: A Human Factors and Usability Case Study

on 22 June 2016 | By Stephen Biernacki

About R&Q's Case Studies: We hope you enjoy our latest 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. FDA Approved: Creating and Implementing a Compliant Usability Engineering Process...
Read More
Clinical Studies | Case Studies | Clinical Evaluation Report

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

on 18 February 2016 | By Stephen Biernacki

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...
Read More
Regulatory Strategy | Case Studies

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

on 15 February 2016 | By Stephen Biernacki

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...
Read More
Remediation | Case Studies | Design History File Remediation

Introducing Our First In A Series of New RQM+ Case Studies: Design History File Remediation

on 12 February 2016 | By Stephen Biernacki

About RQM+ Case Studies: Our goal in producing case studies is to succinctly demonstrate how RQM+ 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...
Read More