incantis GmbH

There are countless jokes about consultants thinking of great solutions without helping their clients in the practical implementation.
Our focus very much lies on an affordable realization of the ideas we conceive of together with you and on helping out and lending a hand.

We aim to support this high standard with our professional expertise and the flexibility of our consulting services.

Our topics:
Products – projects – processes
Quality- Review methods – audits
Technical documentation / Technical writing
Risk management according to ISO 14971 (medical devices)
ISO 13485/FDA 21 CFR Part 820 compliance
New apects of the MDR
Internationalisation and localizing

Company’s Keywords:

qms iso 13485, lean qms, iso14971, postmarketsurveillance, mdsap, mddmdr transition, handson support, risk management, document management, medical devices, audit preparation, technical writing, medical device regulation, validation, technical documentation, audit remediation