Just four Notified Bodies according to MDR 2017 / 745 have been named up to...
With a good quality management system, you ensure that your products and processes comply with the required level of quality and “good practice” standards – from development to patient use.
We advise and support you in the areas of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP):
- Audits (internal, at suppliers, in the warehouse, etc.)
- Preparation of/for inspections
- Product Quality Reviews (PQRs)
- Management of complaints
Outsourcing of the Responsible Person (RP)
If required, we assume the function as your company’s Responsible Person (RP) -outsourced permanently or for an interim period during maternity leave or in the case of staffing shortages:
- Assuming responsibility and overseeing the quality of your products
- Marketing approvals
- Deviation management
- SOP management
Benefit from our expertise and experience in these areas:
- Obtaining an Establishment license in Switzerland
- Evaluation of the required types of permits for your company
If required, we offer the use of our establishment licenses to companies without an establishment of their own in Switzerland until they have obtained their establishment licenses (e.g. import and wholesale license including market release).
Implementation and maintenance of quality management systems
We are happy to advise you in the following areas:
- Evaluation and optimisation of existing quality management systems
- Implementation of new quality management systems
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