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

Amy Castronova

Recent Posts

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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New Clinical Evaluation Report Solution for EU MDR Compliance

As of May 2020, medical device manufacturers who sell devices in Europe must comply with more comprehensive regulations set forth by the European Medical Device Regulation (EU MDR). With numerous clients affected by this, Novatek has launched a Clinical ...
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Cyber Security Plan Helps Client Meet Looming Compliance Deadline

When the New York State Department of Financial Services (DFS) mandated that financial services companies take more extensive cyber security measures to help safeguard their clients’ data, W.J. Cox Associates, Inc. was unsure how they’d find the time and ...
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Medical Device Innovators:  Get Used to Being Uncomfortable

The latest MEDTECH 2018 conference, New York's largest gathering of bioscience and medical technology leaders, brought together experts in regulatory and policy, innovation and technology, and startup/business acceleration. This year’s event, “Building ...
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 EU MDR