Medical Devices

Good international support network

The legal framework for medical devices is determined in the EU by the Medical Devices Directive 93/42/EEC (MDD). This divides medical devices – based on their hazard potential – into four classes (I, II a, II b, III). We advise you with the classification and assist in compiling the technical and regulatory documentation. The classification of your "borderline products" is also in good hands with our specialists. With our subsidiaries and partners we are in a position to open up the global market for worldwide registration of your products. 

Our services with regard to medical devices

  • Strategic and regulatory consulting (also on-site) for worldwide registration
  • Classification of Medical Devices, In-Vitro-Diagnostica and borderline products
  • Clinical and biological evaluation, toxicological characterization
  • Audit trails for ISO 13485, GMP, QSR and medical device directives
  • Supplier audits
  • Perform "friend of the company" QSR compliance audits
  • Manage and respond to FDA and ISO 13485 audits to rectify observed deficiencies
  • Develop and implement QSR and ISO compliance programs customized to company operations
  • Review / preparation on technical documentation files
  • Worldwide product certification / registration please click here.
  • Design dossiers
  • Gap analysis of existing documentation
  • Bill of material structure and product configuration
  • Risk management accord. EN ISO 14971
  • Interaction with Notified Bodies or Authorities
  • EAR and US agent service
  • Establishment registration and device listings
  • Validate products and processes
  • Design controls, corrective action, monitoring and trending programs
  • Reduction of product costs
  • Training on European, Canadian and FDA medical device regulations
  • Training on ISO 13485, ISO 9001 and GMP requirements
  • Training on country specific requirements
Dr. Albrecht Poth Business Development Medical Devices
+49 621 718858-0 send mail

A global network for medical devices

Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!