REGULATION MD-IVD
With the entry into force of the new Regulation (EU)2017/745 and (EU)2017/746 of the European Parliament, it is necessary to meet certain requirements to be able to sell IVD products in the territory of the EU. We guide you in the resgitration, labelling and certification of MD-IVD products to be able to compete in the fast growing IVD European market.
What can we do for you?
Generation of technical documentation to obtain certification or prepare the declaration of conformity.
Preparation and implementation of the Quality Management System, including the applicable procedures and records.
Identification of applicable legislation and harmonized standards.
Management and support during the evaluation of Notified Orgaizations.
Clinical trials management.
Implementation and post-market surveillance, vigilance and market surveillance.
EU Authorised Representative Service.
Advice on product classification, and choice of conformity assessment route.
Service and training of Person Responsible for Regulatory Compliance (PRRC).
Our team of professionals is ready to listen and assist you