CE Marking process - Garza MD

Manufacturers of medical devices need to obtain CE marking on their products, before placing it on the European market. There are a number of regulatory requirements for medical devices which can be found in the Medical Device Directive or Regulation (MDD / MDR). The technical documentation of the product should be well structured and complete to demonstrate compliance to these regulatory requirements.

Garza MD can be of service in setting up, writing and / or structuring of the necessary Technical Dossiers and Design History Files. This assistance can take place in several stages of the product life cycle. From conception to market introduction and post-market activities.

Additional activities offered

Gap analysis for compliance

Classification of devices, systems and accessories