NBOG Publishes revised Notified Body guidance documents

The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents. The

The Notified Bodies Oversight Group (NBOG) has published (Nov. 2014) the following revised Notified Body guidance documents.

The aim of such guidance is to address some of the best practice expected from manufacturers and Notified Bodies.

The guidance documents can be found on the below link:

1. NBOG BPG 2014-3 – Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System
2. NBOG BPG 2014-2 – Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities
3. NBOG BPG 2014-1 – Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules

NBOG Forms;

4. NBOG F 2014-1 – Application form to be submitted when applying for designation as a notified body
5. NBOG F 2014-2 – Qualification of personnel (see NBOG BPG 2014-2)

 


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If you are interested in the European Markets you can contact us for a preliminary discussion.

About nicolas

My name is Nicolas Clary, I'm the founder and CEO of Kobridge Consulting Ltd. in 2006 when I met my wife in Korea I had no idea it would lead me to this. At that time I was already a consultant and regulatory expert for Medtech companies. I was also an auditor for the French Notified Body LNE. In 2007 I decided to move to Korea to establish a consulting business there. At first I was like most my actual clients : completely lost. It took me a lot of time to understand all the regulatory processes in Korea and fortunately I was lucky enough to find the right people. I am much better now at understanding my clients' needs because I've been in their shoes before. I usually say that I'm a translator. Understanding different regulations helps to explain certain requirements (here Korea vs Europe or US). I can also translate the needs of regulatory professionals to sales professionals and vice versa.