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Regulatory Support

The approval process for medical devices is complex and highly regulated. Our team of experts supports medical device manufacturers and suppliers by providing the following services in conformance with the relevant international regulations:

  • Medical device classification and determination of the relevant regulations
  • Identification of the relevant requirements of the medical devices directive (MDD 93/42/EEC) as amended or the medical devices regulation (MDR 2017/745)
  • Identification of harmonised and other relevant standards
  • Quality management in compliance with ISO 13485 and ISO 9001
  • OEM-PLM management
  • Quality assurance agreements
  • Compilation and submission of technical documentation
  • Direct competent authority and notified body communication and collaboration
  • Risk management according to ISO 14971
  • Biological safety according to ISO 10993
  • Project management and support of product development projects, national and international registrations and certifications: CE-Mark, 510(k), etc.
  • Vendor management incl. supplier audits