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PRRC, AR, US AGENT, UKRP | Founder of MedicalRegs & DocuRegs
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Technical File Documentation Template
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Technical File Documentation Template
Quality Assurance - Regulatory Affairs - Consultant (QARA Medical Device - ISO 13485 / MDR IVDR CE)
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Bundle pack of templates (TDF + PMS)
Lead auditor ISO 13485 (QARA)
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365 Questions to evaluate your QMS
We offer free content to simplify (EU) MDR 2017/745 & ISO 13485:2016 accessible to medical devices expert.
We also offer premium content with blue-print templates compliant with (EU) MDR 2017/745 & ISO 13485:2016 to implement in your activities.
We are an independent group of French consultants with several years of experience in various fields (regulatory, clinical, quality).
With our combined experience, we have passed several certification audits with different classes of MD/IVD.
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We are like you, well almost...
We are French consultants with several years of experience in the field of medical device regulation.
We have encountered the same challenges as almost all regulatory experts during the implementation of the EU MDR 2017/745 and EU IVDR 2017/746.
After several years of expertise in implementing these regulations, we decided to share our knowledge and experience to make the regulations accessible to everyone!
Therefore, we created EU MDR COMPLIANCE, which is nothing less than a group of enthusiasts who love regulation (yes, it's possible). But what we love most is sharing, exchanging, and responding precisely to your needs because ultimately, we encounter the same issues!
We share regular content on LinkedIn; you probably met us through this platform!
"It's because we have managed to solve the same problems that every regulatory expert encounters that today we share our knowledge and expertise."