Roland Betz Senior Quality Consultant (Medical Devices or Machinery) supports when:

 

GROWING—You

· want to establish a Quality Management System according to ISO 13485 / US FDA CFR 820 or ISO 9001

· need to be compliant to the EU Machinery Directive / Regulation

· have a new product either for the first time or in another class and need Market Access to the USA (PMA or 510(k) and / or in EU (MPG)

· want establish or update your product development process to develop the right product at the right time.

· feel you need an audit to check compliance or audit a supplier but you are short of resources

 

 

You have a problem

· FDA has asked for an inspection, has sent a Warning Letter or worse or you just want to be prepared

· A Market Retrieval with grave consequences for your company seems to be imminent

· Your Notified Body has refused Market access for a product that you need

· Your product / service / manufacturing process needs review and improvement