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, CMDR 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 very often requires the mandatory use of a third party (e.g. Notified Body in Europe) in the approval or certification process. VTT Expert Services Ltd has been designated as Notified Body for various conformity assessment procedures.
Our services include
- Notified Body services (NB 0537) for 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.
- Audits and assessments of management systems on a voluntary basis.
- Quality management system audits under CMDCAS
- Certification in the Laundry Service Industry against EN 14065.
Notified Body competence
93/42/EEC - Medical devices
98/79/EC - In vitro diagnostic medical devices
Using a third party like a Notified Body is not always mandatory for product approvals. In these cases VTT Expert Services Ltd provides different expert services on a voluntary basis to ensure that your product makes its way to market smoother.
We offer tailored trainings for manufacturers and users related to the requirements, standards and regulatory approval processes.
Why VTT Expert Services Ltd
- Finnish Notified Body since 1995
- Several conformity assessment and audits (CE marking, 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.