for medical devices and quality management systems
Competence and experience make the difference
In more than 16 years in the medical device business - thereof more than 10 years in QM and RA for a major German medical device manufacturer and lastly six years for a German Notified Body - I observed that the difference between the regulatory requirements on one hand and the organisational, professional and financial resources of many manufacturers on the other hand becomes bigger and bigger.
In particular small and mid-sized companies are limited in their resources. It is very difficult and expensive to find skilled personnel but otherwise the label "consultant" is not defined. Therefore it is extremely difficult or even impossible for a manufacturer without relevant skills to assess the competence of a consultant beforehand.
Since all medical device manufacturers for products higher than class I are depending on a Notified Body the benchmark for a good consultancy should be thinking and acting as a Notified Body.
As there are numerous different medical devices, manufacturing processes, applicable standards, relationships to subcontractors (OEM/OBL, PLM, outsourced processes) and additional requirements (NBOG, MEDDEV, ZLG etc.) an extensive experience as auditor and assessor as well as in the medical device industry is crucial.
With the implementation of the new medical device regulations (MDR) and the still not wide spread ISO 13485:2016 the above mentioned difference will become even worse.
Simultaneously the number of Notified Bodies in Europe was reduced dramatically during the last couple of years. Notified Bodies are often overloaded, the processing time increases. Therefore the quality of provided documents and the performance during audits becomes more and more important.
Thus I decided to provide my know how to interested medical device manufacturers.
