Medical Devices 2017-05-16T17:10:15+00:00

Medical Devices

Medical devices, including some oral or topical products, exert their beneficial effects mainly by physical action.

During the past 10 years, a&r was involved in the certification of numerous medical devices in the indications wound healing, weight management, atopic dermatitis, Herpes simples, allergic rhinitis, and parodontosis, among others. a&r is familiar with the compilation of the Technical Documentation for all risk classes and cooperates with national and international Notified Bodies.

Regulatory Affairs

Related to medical devices, a&r supports its clients with the following services:

a&r’s services include:

•    Gap analysis and interpretation of all relevant product-specific data
•    Check of regulatory requirements for a medical device
•    Clarification of demarcation issues (medical device – food – drug)
•    Compilation of the technical documentation
•    Coordination of required in vitro, in vivo, and/or clinical studies
•    Correspondence with Notified Bodies
•    Consultation procedure in case of medical devices with pharmacological substances (Class III)