incantis GmbH
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We are motivated, flexible and creative and will support you with whatever task may have come your way!
Not only will we be aiding you in finding solutions to your problems and concerns, but also supporting the concrete implementation of the necessary documentation and trainings to ensure long-lasting stability of the effects of our work.
Since the company's founding in 2009, our young team will bring you the fresh ideas and modern solutions you are looking for to ensure conformity not just today, but tomorrow.
Using our experience working with companies all over the medical devices/pharmaceuticals industry and in contact with our wide-ranging international network of colleagues, no problem will be left unsolved!
Topics:
- Products - Projects - Processes
- Quality Management - Audits
- Technische Dokumentation / Technical Writing
- Risk management acc. to ISO 14971
- ISO 13485/FDA 21 CFR Part 820 compliance
- Adjusting to MDR
Keywords
qms iso 13485, lean qms, iso14971, postmarketsurveillance, technical documentation, audit remediation, medical devices, audit preparation, risk management, medical device regulation, validation, technical writing, handson support, document management, mdsap, mddmdr transition
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