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 Audits: Big Changes – Big Headaches
By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: December 15th, 2014
The new Regulatory Framework for medical devices currently being considered in the European Union will no doubt bring about many significant changes to manufacturers. These changes will encompass stringent Notified Body requirements and oversight coupled with increasing Notified Body authority. These changes will in turn affect your audit experience. Read More
Updating Technical Files – Is Your Company Ready for a Notified Body Audit?
Did you miss the recent webcast “Updating Technical Files – Is Your Company Ready for a Notified Body Audit?” You can listen to it here!
Preparing for a Notified Body Audit
By Ron Sills, M.S., Nerac Analyst,
Originally Published: October 3rd, 2014
Is your company ready for an audit by your notified body? Read more