Medical device consultancy​

✓ 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​
  

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Our track record

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• ​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