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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: remediation
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The Road to Remediation: Ensuring Quality, Safety, and Compliance in MedTech
on 29 May 2024 | By Scott Edwards, Managing Director, RQM+
Most of us are familiar with the fast-paced world of MedTech and the mounting pressures to maintain product quality, safety, and compliance companies face. With the FDA increasing the number of Class I recalls and the EU MDR/IVDR placing greater responsibilities on the Person...
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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...
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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...
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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?...
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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...
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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...
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Preparing For Fda Visit | Regulatory Harmonization | Remediation | Australia | Fda | New Zealand | Medical Device | Regulatory News | White Paper
Regulatory Intel - Jan. 14, 2013 Quick-Hits
on 14 January 2013 | By Ryan Kasun
A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:
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