qcmed
qcmed GmbH is a leading medical consulting company with over 20 years of experience, specializing in regulatory approval, quality management systems, and training for medical device manufacturers, operators, and users worldwide. They focus on tailored solutions, strategic planning, and practical implementation to ensure compliance with international standards and regulations, supporting clients in bringing medical devices to market efficiently and safely.
Industries
Nr. of Employees
small (1-50)
qcmed
Services
Development of international approval strategies, product classification, conformity assessment selection, preparation of technical documentation and coordination with notified bodies and authorities.
Setup, maintenance and review of QMS including QM manuals, SOPs, process optimization, CAPA and internal/supplier audits aligned to ISO and regulatory requirements.
Advisory and project support for cleanroom production, sterilization validation, process validation, test equipment management, packaging validation and device refurbishing processes.
Design and coordination of testing programs covering biocompatibility, electrical safety/EMC, usability, implant testing and extractables through partnered laboratories.
Planning and execution of software validation programs and offering of fully digital/remote audit services.
Tailored training sessions and workshops on medical device regulation, quality management and compliance topics delivered in small groups or at client sites.
Development of international approval strategies, product classification, conformity assessment selection, preparation of technical documentation and coordination with notified bodies and authorities.
Setup, maintenance and review of QMS including QM manuals, SOPs, process optimization, CAPA and internal/supplier audits aligned to ISO and regulatory requirements.
Advisory and project support for cleanroom production, sterilization validation, process validation, test equipment management, packaging validation and device refurbishing processes.
Design and coordination of testing programs covering biocompatibility, electrical safety/EMC, usability, implant testing and extractables through partnered laboratories.
Planning and execution of software validation programs and offering of fully digital/remote audit services.
Tailored training sessions and workshops on medical device regulation, quality management and compliance topics delivered in small groups or at client sites.
Expertise Areas
- Regulatory compliance for medical devices (MDR, IVDR, CE marking, FDA)
- Quality management systems (ISO 9001, ISO 13485, ISO 15378, US QSR)
- Risk management and post‑market surveillance
- Validation and verification (sterilization, processes, software)
Key Technologies
- Technical documentation (DMR / DHF) preparation
- Regulatory submission processes (CE, 510(k), PMA, IDE)
- ISO 14971 risk management framework
- Process and sterilization validation methodologies
News & Updates
The EU has postponed the MDR application date to May 26, 2021, providing more time for preparation.
Support for digital audits in line with current contact restriction guidelines.
Meet qcmed at Medica 2020 in Düsseldorf.
The DMEA conference is held online this year, and qcmed is available digitally, by phone, and via video conference.
qcmed is certified according to DIN EN ISO 9001.
The EU has postponed the MDR application date to May 26, 2021, providing more time for preparation.
Support for digital audits in line with current contact restriction guidelines.
Meet qcmed at Medica 2020 in Düsseldorf.
The DMEA conference is held online this year, and qcmed is available digitally, by phone, and via video conference.
qcmed is certified according to DIN EN ISO 9001.