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Medical Device & Healthcare

Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A 3-Part Nerac Perspective

By Richard Conforti, M.S.
Originally published August 15, 2016
This is a 3-part series of articles on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. The third article describes the final clinical literature report.
Read all three here

Patents and Medical Devices: Protecting your Business Through Intellectual Property

By Ron Sills M.S., Nerac Analyst,
Originally Published: July 6th, 2015
This article describes how medical device manufacturers can and should protect their products and business interests through patent protection. This includes not only patent protection of their own intellectual property, but actively monitoring the industry to ensure there is no infringement on their intellectual property.
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Establishing State-of-the-art Compliance for Medical Devices

By Ron Sills, M.S., Nerac Analyst
Originally Published: June 22nd, 2015
The regulatory changes occurring in the EU have resulted in an increased scrutiny for many medical device manufacturers. In Nerac’s experience, notified bodies have shown an increased emphasis on the clinical evaluation reports which support the safety and performance of approved devices.
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Notified Body Audit Trends: Be in the Know!

By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: February 10, 2015
With Notified Bodies being periodically audited, it is important to understand that they will be reviewing your technical documentation with a much more critical approach. As the new regulatory framework is passed and implemented, further changes will increase Notified Body expectations. Auditors will continue to identify areas of concern and medical device manufacturers will need to stay vigilant regarding the findings of the Notified Body auditors in order to keep ahead of the expectations. Make sure you understand these trends!! Read More