We understand time to market is critical for manufacturers of medical and In-Vitro Diagnostics (IVD) devices, and DEKRA anticipates this need by allocating a dedicated Project Manager to streamline Design Dossier review and submission activities across the globe. Our one-stop-shop for medical device manufacturers includes:
- Medical Device Directive (MDD) - DEKRA issues and assumes Notified Body CE certificates for medical devices testing intended for sale in the European Union. Combining CE marking with ISO 13485 Quality Management System certification offers efficiency and savings through a consolidated DEKRA evaluation.
- In Vitro Diagnostic Device Directive (IVDD) - The European Union has special requirements for IVDD manufacturers selling into the EU market. We offer certification of List A, List B and self-test IVD products.
- Tissues of Animal Origin - DEKRA certifies medical devices which incorporate tissues of animal origin in accordance with the Animal Tissue Directive and in combination with the MDD.
- Drug-Device Combinations - DEKRA has extensive experience in working with European drug authorities for certification of devices which incorporate medicinal substances.
- Active Implantable Medical Device Directive (AIMDD) - The European Union also has special requirements for manufacturers of active medical devices intended to remain permanently in the body. DEKRA is accredited and experienced in the issue of certificates for these high-risk devices.
- IEC 60601 - DEKRA coordinates the testing required by the EU for CE certification of medical and other devices, and works with our clients to shorten the time to market throughout the process.
- FDA 510(k) - DEKRA offers expedited certification faster than submission directly to the US Food and Drug Administration (FDA). DEKRA also offers consolidation of required QSIT inspections performed on behalf of the FDA with your quality system audits.
- Electromagnetic Compatibility (EMC) - DEKRA is a Notified Body and Competent Body for R&TTE Directive (Radio and Telecommunications Terminal Equipment) testing for the EU and for electromagnetic interference (EMI) and radio frequency interference (RFI) testing for the US market.
- Canadian Medical Devices Conformity Assessment System (CMDCAS) - DEKRA is a recognized registrar for the Canadian medical market, and can arrange for consolidation of audits for required Quality Management System and CE certification audits.
Click here to learn more about DEKRA Certification's services for Medical Device manufacturers.