CONSULTING FOR MEDICAL DEVICES, HEARLY RATE

€75.00

We navigate the regulatory path together.
We guide you through compliance with MDR (EU) 2017/745, IVDR (EU) 2017/746, FDA 21 CFR 820, and ISO 13485:2016 to bring your medical device to market.

Service coverage:

  • Gap Analysis (regulatory and compliance gap assessments)

  • Implementation of Quality Management System (ISO 13485:2016, Clause 4)

  • Product qualification and classification (MDR Annex VIII / IVDR Annex VIII)

  • Support in drafting the Design Dossier and Technical Documentation (MDR Annex II / Annex III)

  • Support in Clinical Evaluation (MDR Article 61 / IVDR Article 56)

  • Post-Market activities management (MDR Articles 83–92 / PMS Surveillance)

Price excluding VAT

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