Inmedis
Consultancy focused on quality management and regulatory affairs for medical device companies. Services include development and optimisation of QMS (ISO 9001 / ISO 13485 / FDA QSR), regulatory strategy and registrations, MDR-compliant technical documentation, validation of design and manufacturing processes (including CSV), biocompatibility planning per ISO 10993, and post-market surveillance/vigilance support. Offers outsourced QM/RA leadership, trainings and market resources such as eQMS provider listings and MDR transition summaries.
Industries
Nr. of Employees
small (1-50)
Inmedis
Bahnhofstrasse 27, CH-6300 Zug, Switzerland
Products
QM-Systems
Services for implementing and maintaining quality management systems compliant with standards like ISO 9001, ISO 13485, FDA QSR, and MDSAP.
QM-Management
Outsourcing and coaching services for quality management and regulatory affairs functions in medical technology companies.
Technical Documentation
Preparation and review of technical documentation compliant with Medical Device Regulation (MDR) requirements, including gap analyses and document reviews.
Validation
Validation services for design, manufacturing processes, and computerized systems in medical device production.
Biocompatibility
Planning and execution of biocompatibility testing according to ISO 10993 standards for medical devices.
Regulatory Affairs
Support for regulatory strategy development, product registrations, and monitoring of market and standards for medical devices.
QM-Systems
Services for implementing and maintaining quality management systems compliant with standards like ISO 9001, ISO 13485, FDA QSR, and MDSAP.
QM-Management
Outsourcing and coaching services for quality management and regulatory affairs functions in medical technology companies.
Technical Documentation
Preparation and review of technical documentation compliant with Medical Device Regulation (MDR) requirements, including gap analyses and document reviews.
Validation
Validation services for design, manufacturing processes, and computerized systems in medical device production.
Biocompatibility
Planning and execution of biocompatibility testing according to ISO 10993 standards for medical devices.
Regulatory Affairs
Support for regulatory strategy development, product registrations, and monitoring of market and standards for medical devices.
Services
Development and optimisation of quality management systems and audit readiness for ISO 9001, ISO 13485 and FDA QSR compliance.
Outsourcing of QM/RA functions, interim quality management and coaching to maintain operations or support improvements.
Creation and optimisation of MDR-compliant technical documentation in German and English, including clinical evaluation and market surveillance content.
Validation planning and execution for design transfer, manufacturing and sterilisation processes, including DQ/IQ/OQ/PQ and packaging/shelf-life simulations; computer system validation using a risk-based approach.
Planning and coordination of biocompatibility evaluations per ISO 10993, including risk-based test plans, coordination with qualified labs, and report preparation.
Regulatory strategy, registrations and market surveillance services, including UDI introduction, coordination with notified bodies/authorities, EUDAMED administration and PRRC support.
Development and optimisation of quality management systems and audit readiness for ISO 9001, ISO 13485 and FDA QSR compliance.
Outsourcing of QM/RA functions, interim quality management and coaching to maintain operations or support improvements.
Creation and optimisation of MDR-compliant technical documentation in German and English, including clinical evaluation and market surveillance content.
Validation planning and execution for design transfer, manufacturing and sterilisation processes, including DQ/IQ/OQ/PQ and packaging/shelf-life simulations; computer system validation using a risk-based approach.
Planning and coordination of biocompatibility evaluations per ISO 10993, including risk-based test plans, coordination with qualified labs, and report preparation.
Regulatory strategy, registrations and market surveillance services, including UDI introduction, coordination with notified bodies/authorities, EUDAMED administration and PRRC support.
Expertise Areas
- Quality management systems (ISO 13485, ISO 9001, FDA QSR)
- Regulatory affairs and market access (EU, US, CA, CN)
- MDR-compliant technical documentation and clinical evaluation
- Validation (process, sterilisation, DQ/IQ/OQ/PQ, computer systems validation)
Key Technologies
- ISO 13485 / ISO 9001
- FDA Quality System Regulations (21 CFR 820)
- GAMP 5 / risk-based CSV
- ISO 10993 biocompatibility framework
News & Updates
Published a compiled list of eQMS providers for medical technology and invited industry feedback; dataset available for download.
Overview and analysis of MDR transition periods by device class including updated EUDAMED roadmap; downloadable summary document.
Statement that from January 2026 inmedis and Imfeld Unternehmensberatung will combine services under a joint umbrella and plans to convert to a public limited company during 2026.
Published a compiled list of eQMS providers for medical technology and invited industry feedback; dataset available for download.
Overview and analysis of MDR transition periods by device class including updated EUDAMED roadmap; downloadable summary document.
Statement that from January 2026 inmedis and Imfeld Unternehmensberatung will combine services under a joint umbrella and plans to convert to a public limited company during 2026.