Services >> Certification and Product Approval >> Medical Devices

Medical Devices

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The market for healthcare products is global but the industry is heavily regulated in all important market areas. Regulatory approval methods in the countries with the largest market potential are different, complex, and unfortunately only in few cases mutually recognized.

Products must comply with EU Directives in the European Economic Area, FDA's requirements in the United States, Health Canada's requirements in Canada, JPAL regulations in Japan, TGA requirements in Australia. In addition, many important countries globally have their own regulatory systems for medical devices.

Placing medical devices on the market often requires the mandatory use of a third party (e.g. Notified Body in Europe) in the approval or certification process. Eurofins Expert Services is designated as Notified Body for various conformity assessment procedures.

Our services include

Notified Body services (NB 0537) for conformity assessment (CE marking) of products for the European market (Medical Devices: MDD 93/42/EEC;

  • In Vitro Diagnostic Devices: IVDD 98/79/EC).
  • Certification of quality management systems against quality management system standard ISO 13485 on a voluntary basis.
  • Quality management system audits under MDSAP (Medical Device Single Audit Program)
  • Certification in the Laundry Service Industry against EN 14065.

Notified Body competence

Eurofins Expert Services

  • Previously known as VTT Expert Services
  • Finnish Notified Body since 1995
  • Audits related to the conformity assessment (CE-marking) of medical devices and to the certification of the quality management system (ISO
  • 13485, ISO 9001) are possible to be combined.
  • We have clients in Europe, Asia, North America and South America. The number of our international clients is growing.

Impartiality Commitment

Our top level management's commitment to impartiality.