- SERVICES PROVIDED IN CONNECTION WITH CONFORMITY
ASSESSMENT OF ACTIVE IMPLANTABLE MEDICAL DEVICES
- Conformity assessment by the
Notified Body No. 1023
according to the requirements of the Council Directive 90/385/EEC, laying down
the technical requirements for active implantable medical devices.
- The Applicant shall select the method of conformity assessment
in accordance with the Government Order the Council Directive 90/385/EEC
- Conformity assessment procedures
- Quality system assessment by the
Notified Body (total quality assurance system);
- Type examination by the Notified
Body and verification of conformity with the certified type
- Accredited Laboratory
No. 1004 and No. 1004.3
- Technical inspection - statistical
Granting licences for the voluntary certification mark
"ITC certified quality"
- ITC grants a license for the use of the
quality mark, which is granted to the products where high standard of safety and
quality parameters has been proved by certification and where meeting the prerequisites
of the producer for continuous quality compliance has been proved through inspection
visits.
- Standardization services - search for standards,
analyses of technical information, borrowing of standards
- Certification of management systems (ISO
13485, ISO 9001,
ISO 14001, OHSAS 18001
- Technical inspection - statistical inspections,
inspection certificates
- PRODUCTS ASSESSED IN ITC ACCORDING TO the Council
Directive 90/385/EEC
Institute for Testing
and Certification, a joint-stock company is notified for conformity assessment of
active implantable medical devices in full scope of the Council Directive 90/385/EEC.
|