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representative functions
You cannot fulfill the legal requirements for representatives by your own and you need an external solution?
The Medical Device Law forsees the designation of a Safety Officer for Medical Devices and its deputy.
The EU Regulations IVDR and MDR which are valid from May 2017 require the designation of a Person responsible for regulatory compliance.
These statutory requirements are linked to particular experiences and qualifications of the personnel which maybe difficult to be fulfilled by small and midsized companies.
However the legislator forsees that a manufacturer may designate external personnel for these positions; in the case of the person responsible for regulatory compliance the various tasks maybe assigned to several persons.
Due to my professional experiences and my professional career I fulfill all statutory requirements of the representative positions described. For example for 10 years I was Safety Officer for Medical Devices according to §30 Medical Device Law (MPG).
Of course you can delegate the position of the Quality Management Representative (QMR) of your QM system to an external person.
As part of my consulting services I would be glad to take up these functions in your company!
medlaQ - Consulting for medical devices
Dr. Bernhard Gerstenecker
GENERAL INFORMATION
ADDRESS
medlaQ
Dr. Bernhard Gerstenecker
Scheffelstraße 9
78315 Radolfzell
Tel.: +49 172 3792283