CLINICAL LABORATORY REGULATION MD-IVD
Certain requirements are necessary to meet the new Regulation (EU) 2017/745 and (EU) 2017/746 of the European Parliament regarding IVD products within EU territory.
What can we do for you?
Generation of technical documentation.
Preparation and implementation of the Quality Management System, including the applicable procedures and records.
Identification of applicable legislation and harmonized standards.
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