Active Implantable Medical Devices

The medical device sector is one of the most competitive in the world because product average lifespans are very short. To sell products on the EU market, they must conform with the Medical Devices Directives. Conformity assessment for active implants and the CE marking open access to the European market. EU Directive 90/385/EEC sets the requirements for active implantable medical devices on the European market.

Based on your needs:

• Assess product design and establish a quality management system
• Set quality assurance rules with EC type examination and interpretation
• Technical file preparation and review services

Benefits

• Guides you through every requirement needed to sell your product on the European market
• Competitive edge: the quality and reliability of active implants build client trust.
• Connects you with a network of highly qualified medical device specialists

Conformity assessment procedure. Optional pre-audit: the scope of this review is defined to fit your needs. At the close of the pre-audit, we prepare an audit report that lists potential areas for improvement. Initial certification audit, Stage 1: an on-site company audit, or an analysis of all required information about the company, is carried out to determine readiness for certification. Stage 2: based on the audit plan shared in advance, the assessment confirms whether processes meet the requirements of the relevant directives and standards. A detailed audit report is issued at the close of the audit. Certificate / Approval: if the audit results are positive, approval is issued for the conformity assessment procedure. It is renewed through a surveillance audit every 12 months and a recertification audit every 5 years.

Declaration of conformity: for your products that close the audit successfully, the products can be marketed with the declaration of conformity and the CE marking, including the notified body's identification number.

Product examples

• Implantable hearing devices
• Pacemaker systems
• Implantable infusion pumps
• Cochlear implants and accessories
• Insulin pumps
• Retinal implants