Medical device consultancy

Development, manufactoring, sale/distribution, PMS and regulatory.

Our insights

✓ Compliance with ISO 13485 & ISO 14971

✓ Compliance with FDA 21 CFR Part 820 & MDD Internal & External Quality Audits

✓ Quality Assurance & Management

✓ Risk Management (acknowledged tool package)

✓ Change Management

✓ Unique Device Identification (UDI)

✓ Medical Device Regulation incl. CE Marking

✓ Handling of Complaint files

✓ Production and Process controls Combination

✓ Products

✓ R&D Documentation and maintenance

✓ QP – Qualified Person(s)

✓ Process Validation (IQ, OQ, PQ) Sterilization of

✓Medical Devices

Specialists in all MD classes (I, II
and III)
Ensure up-to-date knowledge with regulations and guidelines
Large professional network
Consultants with different professional backgrounds ensures the right people for the right job
Experienced quality auditors

QA track lead
Implementation and application of QMS
Interpretation of ISO13485, ISO14971, MDD and FDA 21 CFR Part 820 -> Securing compliance
GMP training and compliance analysis
Process analysis incl. validation, mapping and monitoring
Analysis of existing root causes and CAPA’s