Medical Device Consulting
Medical Device Consulting
Integrative and comprehensive quality management concept for medical devices
- Consulting in the medical device environment throughout the entire product and quality management system lifecycle
- Management consulting for strategic regulatory pathways
- Regular professional development courses for EUMEDIQ consultants to meet current and upcoming requirements
- Proven track record of all consultants in the medical device industry
Optimised quality management processes with eQMS
- Management system implementation support
- Medical device eQuality management system according to ISO 13485
- Information security management system according to ISO 27001 (and sub-standards)
- In conjunction with lifecycle management systems (PLM/ALM)
- In conjunction with enterprise resource planning (ERP)
- Compliance of electronic records and digital signatures
- 21 CFR Part 11
- eIDAS Regulation (EU 910/2014)
Holistic approach for management systems
- Data privacy protection and security related consulting in the medical device industry (GDPR, US HIPAA, NIST etc.) as a part of our information security management support
- Strategic and regulatory project management for the implementation of small to large-scale projects in the medical device industry
- Information security management aspects (ISO 27001, ISO 27017 and NIST Cybersecurity Framework 2.0)
- Computerized system validation expertise
With our accumulated expertise and know-how in the MedTech sector, we will find the right approach for exactly your individual requirements.