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Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Top 5 IVDR 2017/746 FAQs

Similar to the EU Medical Device Regulations (MDR), the new In-Vitro Device Regulations (IVDR 2017/746) are set forth to increase patient safety. To successfully transition to the new regulations, manufacturers need to prepare their products and ...
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Who's On Your Clinical Evaluation Report Team?

As organizations grapple with the challenges of developing an EU MDR-compliant Clinical Evaluation Report (CER), the first question after “What is a CER?” is usually, “Who will write it?” Assembling the right team with the right skill set is critically ...
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 EU MDR