Health technology: medical devices

Are you puzzled by the new MD and IVD regulations on medical devices? Are you lost in the jungle of different authorities and health technology-related requirements? We know what needs to be done and when to place your products on the market.

Our team will find fast and the most suitable routes for your company in different phases of the life cycle of your medical devices (MD or IVD devices). We can give comprehensive guidance to lead you through the regulatory jungle concerning classification, identification of requirements, documentation, quality-related issues and regulatory affairs.

We are highly experienced experts in health technology, for example in the following areas:

  • Entry into EU markets
  • Monitoring, emergency systems and alerts after entry into market
  • Emergency alerts
  • Quality system (ISO 13485)
  • Technical documentation
  • Risk assessment, clinical trial
  • Biological safety assessment
  • Cooperation with authorities
  • Communications with the reported institute
  • Various classifications (e.g. medicinal product/medical device), registration processes and medicinal product/medical device combinations
  • Databases (EUDAMED)
  • Borderline products
  • Audits
  • Person Responsible for Regulatory Compliance (PRRC)
  • Health economics report
  • Hospital tenders
  • Translations related to devices, for example promotional material, user manuals
  • Promotional material review
  • Artwork design

Correct classification spares you many problems