Smooth market introduction of medical devices

Regulatory affairs in medical technology are often perceived as an aggravating factor in the development of medical devices. Development department and the Regulatory Affairs department are sometimes rather confrontational towards each other, resulting in unnecessary friction losses. Solnovis has many years of experience in development and manufacturing and can therefore, as an RA consultant, find intersections between the sometimes conflicting requirements in order to quickly come to an efficient approach.

Regulatory Affairs Regulatory Affairs

A large number of steps are required for the approval and market launch of medical devices. Depending on the target market and the local regulatory and normative requirements, we support you in the approval process (CE, USA and international) as well as in external and internal audits.

Our solution-oriented strategies ensure a cost-effective, efficient and rapid market launch of your medical product.

Solnovis is certified in the following areas:

  • ISO 13485
  • ISO 9001
  • FDA 21CFR820 (our QM system fulfills the processes according to this regulation)

Our services at a glance

  • Quality Management consulting (EN ISO 13485, EN ISO 9001, 21CFR820)
  • Conformity assessment according to EU MDR (Regulation EU 2017/745)
  • Process definition and optimization
  • Preparation for external audits (FDA, notified bodies, authorities)
  • Preparation and execution of internal audits
  • Product design documentation and requirement engineering
  • International Regulatory Affairs (CE, USA und international)
  • Risk management according to ISO 14971
  • Software documentation according to IEC 62304
  • Usability according to IEC 62366
  • Safety of medical devices according to IEC 60601-1, especially in the areas of electrical safety and EMC
  • Biocompatibility according to ISO 10993
  • Standards and regulations in the field of optics, lasers and LED technology
Medizintechnik Beratung