Case-study-background

Blog

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 ...
Read More

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 ...
Read More

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 ...
Read More

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 ...
Read More

FAQs:  How and Why to Budget for Medical Device Product Documentation

When launching a medical device product, providing easy-to-use, accurate instructions are critical  in order to operate, service, or sell the device. But developing highly professional product documentation requires a certain skill set that may extend ...
Read More
 EU MDR