Active Implantable Medical Device Directive (90/385/EEC).
You manufacture active medical devices intended to remain permanently in the body. These active implantables are only allowed on the European market if they comply with the Active Implantable Medical Device Directive (90/385/EEC).
KEMA has been officially designated to review the compliance of products to the essential requirements of the AIMDD for access to the European market. KEMA is also accredited to grant access to markets in other countries. Moreover, you can call on KEMA for certification of your Quality Management System according to
ISO 13485. On March 21, 2010 Directive 2007/70/EC will be in place and mandatory for medical device manufacturers.
KEMA: One-stop shopping- KEMA has a global presence
- All your testing and certificates at one institute: In addition to the AIMD Directive, you can also call on KEMA for IEC 601 tests, R&TTE, 510(k) reviews, and ISO 13485
- Specialists with extensive experience in the medical industry assess your products
- You have one permanent contact throughout the entire process
- KEMA participates in all the MRAs (i.e. US, Japan, Taiwan, Australia)
- KEMA is an expert in drug/device combinations and products with animal material
- KEMA keeps your time to market as short as possible and has developed a special program for this
- Dissatisfied with the service you receive from your present Notified Body? KEMA has experience in assuming certificates.
More information? Contact us.