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Call us todAY +45 ​5189 6887

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​

Why us​?

  • 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​

Our track record

  • ​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

the firm

SMJ Consulting

Vigerslevvej 242, 2. tv.

DK- 2500 Valby

CVR: 32749542

Contact us

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