Quality and regulatory

Plan 1 Health’s quality system is certified according to EN ISO 13485:2016, and operates in accordance to EU Directive No. MDD 93/42/EEC and according to the regulatory requirements related to the canadian market (SOR/98-282).

Notified body is DEKRA Certification B.V.

The certification of the quality management system, is a guarantee that the organization provides products and services according to applicable laws and regulations, through the application of organizational models tested, monitored and constantly improving .

All medical devices placed on the market by Plan 1 Health are CE marked, which means that all the requirements of the Directive 93/42/EEC are satisfied.

The Company has a significant experience in the registration of its products on extra-european markets; this is often a critical and time-consuming stage that has to be completed before putting the medical devices on most of the markets.
Plan 1 Health has been certified since 1996.