Medical Devices & In Vitro Diagnostic (IVD)

C.A.T has many years expertise in the Medical Device & In Vitro Diagnostic (IVD) market.

Why C.A.T Consulting

C.A.T consulting has for many years registered IVD's and medical devices worldwide including the following countries;

Brasil, Turkey, Taiwan, Argentina, Korea, Cuba, China, South Africa, Australia, Venezuela, Philippines, Mexico, Colombia, Costarica, Russia 

Our Services

C.A.T consulting services are tailored to each client and include the following;

• Assistance for companies in understanding and complying with European medical devices requirements
• Identification of national language requirements
• Identification of national medical device registration requirements and completion of the registration process
• Contacting Notified Bodies to carry out activities related to the CE marking process
• Serving as the official contact with European authorities if a Member State takes measures to withdraw a medical device from the market or prohibits or restricts its being put into service
• Receiving and transmitting information on adverse events related to a medical device
• If a  medical device is intended for clinical investigations, notifying European authorities of the Member States in which clinical investigations are to be carried out
• Maintaining technical documentation and clinical evaluation reports within the EU