ONGOING REGULATORY SUPPORT SERVICE

From €500.00

Flexible technical-regulatory support tailored to your needs. Your strategic partner throughout the entire product lifecycle—from initial concept to post-market surveillance. Guaranteed availability from medical device experts to support you at every stage.

Available Plans:

  • Basic Package: 10 hours/month – €500 + VAT

  • Standard Package: 20 hours/month – €1,000 + VAT

  • Advanced Package: 40 hours/month – €2,000 + VAT

  • Premium Package: 60 hours/month – €3,000 + VAT

Rate: €50.00/hour excluding VAT

Service coverage (within agreed hours):

  • Ongoing support throughout all product lifecycle phases (ISO 13485:2016, Clause 7.3 – Design and Development)

  • 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)

  • Real-time support for drafting development files (Design History File – DHF)

  • Technical Documentation writing (MDR Annex II / Annex III)

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

  • Ongoing monitoring of regulatory records and documentation

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

Exclusive Benefits:

  • Guaranteed support from design to post-market

  • Response time <24 business hours

  • Priority access for urgent inquiries

  • Document review included

  • No long-term commitment required

Price excluding VAT

Home