Medical Devices

OUR TEAM SUCCESSFULLY BRINGS MEDICAL DEVICE AND IVD PRODUCTS TO MARKET BY PROVIDING COMPETENT REGULATORY STRATEGIES AND SERVICES THROUGHOUT THE PRODUCT LIFE CYCLE.

Medical Devices

PTR is a joint venture of Dr. Regenold GmbH and CEplus GmbH is an international affiliate of Dr. Regenold GmbH, specialized in regulatory strategy and implementation for medical devices and in vitro diagnostics. The core competency of CEplus lies in CE marking for European markets, customized quality management systems, and any other activities that help clients realize market success.

Additionally, relationship with regulanet® allows us to access resources and manage complex international projects. Particularly in Portugal, we assist companies in complying with legal obligations related to the portuguese market, such as registration of medical devices in the database of the competent authority, as manufacturer and/or distributor, notification of distribution activity to national competente authority, translation of packaging materials, among others.



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