inmedis GmbH

inmedis is your Swiss partner for quality management and regulatory affairs in the medical device industry. Our experienced experts support you pragmatically and goal oriented in the following areas:

– Quality management systems:
ISO 9001 / ISO 13485 / FDA QSR / Audits / MDSAP

– Interim Quality Management Resources:
Outsourcing of QM/RA functions / coaching and support

– Technical Documentation:
MDR-compliant technical documentation / gap analyzes / reviews

– Validation:
Design and manufacturing processes / Computer systems (CSV)

– Biocompatibility:
Planning and implementation / ISO 10993

– Regulatory affairs:
Approval strategy and registrations / Post-market surveillance and standards monitoring

Company’s Keywords:

regulatory affaires, quality management, iso 9001, 13485 certification, risk management, biocompatibility