Integrative and comprehensive consulting across the full medical device and quality management system lifecycle
EUMEDIQ provides medical device consulting services covering regulatory strategy, quality management system implementation, information security, data privacy, and project management, with a proven track record in the medical device industry and supported by regular professional development.
WHAT WE DO
Expert consulting across regulatory affairs, quality management, and information security
EUMEDIQ's medical device consulting services cover the product and quality management system lifecycle, from strategic regulatory pathway planning and management system implementation through to data privacy compliance, information security management, and computerised system validation.
Our consultants bring a proven track record in the medical device industry, supported by regular professional development to ensure current and emerging regulatory requirements are consistently reflected in every engagement, tailored to the individual requirements of each manufacturer.
KEY STATS
10+
10+ years average
employee experience in the
MedTech industry
3 Offices
Headquatered in Zug, Switzerland, operating from Hardt, Germany and London, UK.
3
Core disciplines Regulatory affairs, quality management, and information security covered.
CONSULTING
Consulting across the full product and QMS lifecycle
EUMEDIQ provides integrative and comprehensive quality management consulting for medical device manufacturers, covering every stage of the product and quality management system lifecycle. Our consultants bring a proven track record in the medical device industry, supported by regular professional development to ensure our guidance reflects both current and upcoming regulatory requirements.
Our services cover data privacy and security consulting, strategic regulatory project management, and computerised system validation expertise, all delivered as part of an integrated management system approach tailored to the specific requirements of each manufacturer.
Regular professional development
EUMEDIQ consultants undergo regular professional development courses to ensure their guidance consistently reflects current and upcoming regulatory requirements across every framework they work within.
Strategic regulatory pathway management
Management consulting for strategic regulatory pathways, covering device classification, conformity assessment route selection, and regulatory submission strategy across the EU, UK, Swiss and aligned with US markets.
End-to-end management system consulting
Structured support for the implementation or optimisation of management systems, according ISO 13485 and ISO 27001. Tailored to the specific organization and regulatory requirements of each manufacturer.
eQMS IMPLEMENTATION
Optimised quality management processes through electronic quality management system implementation
EUMEDIQ supports medical device manufacturers in implementing and optimising electronic quality management systems in accordance with ISO 13485, fully integrated with lifecycle management systems, enterprise resource planning systems, and information security management frameworks. Our eQMS implementation services cover all aspects of electronic records and digital signature compliance applicable to regulated medical device environments.
Electronic records and digital signatures
Compliance consulting for electronic records and digital signatures under 21 CFR Part 11 and the eIDAS Regulation (EU 910/2014), ensuring the validity and integrity of electronic quality management documentation.
ELECTRONIC RECORDS
Compliance
PLM/ALM/ERP and MES integration
eQMS implementation in conjunction with lifecycle management systems and enterprise resource planning systems, ensuring full integration across the manufacturer's operational infrastructure.
PLM/ALM/ERP/MES
Integration
ISO 27001 information security management
Information security management system implementation according to ISO 27001 and applicable sub-standards, integrated with the manufacturer's existing quality management framework.
ISO 27001
Info management
ISO 13485 eQMS
Medical device eQuality management system implementation according to ISO 13485, covering process design, document control, CAPA frameworks, and certification readiness.
ISO 13485
eQMS
Management system implementation support
Structured support for the implementation and optimisation of quality management systems, tailored to the specific structure and regulatory requirements of each manufacturer.
QMS
Implementation
HOLISTIC APPROACH
An integrated approach to data privacy, information security, and regulatory project management
EUMEDIQ takes a holistic approach to management system consulting, recognising that data privacy, information security, and regulatory compliance are interconnected components of a robust and audit-ready organisational framework rather than independent disciplines to be addressed in isolation.
Our services cover data privacy and security consulting under GDPR, US HIPAA, and NIST, information security management under ISO 27001, ISO 27017, and the NIST Cybersecurity Framework 2.0, strategic regulatory project management for small to large-scale projects, and computerised system validation expertise, all delivered as part of an integrated approach tailored to the specific requirements of each manufacturer.