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- SERVICES PROVIDED IN CONNECTION WITH CONFORMITY
ASSESSMENT OF MEDICAL DEVICES
- Conformity assessment by the
Notified Body No. 1023 according to the requirements of the Council Directive
93/42/EEC, laying down the technical requirements for medical devices
- The Applicant shall select a method of conformity assessment according
to the classification of the medical device:
- - quality system assessment by the
Notified Body (total quality assurance system);
- type examination of the medical device by the Notified Body and verification of
conformity with the certified type;
- type examination of the medical device by the Authorized
Body and assessment of production quality management system;
- type examination of the medical device by the Authorized
Body and assessment of product quality management system;
- assessment of production quality management system;
- assessment of product quality management system.
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 Testing in the Accredited Laboratory
No. 1004 and No. 1004.3
- Granting licenses for 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 servicessearch for standards,
analyses of technical information, borrowing of standards
- Certification of management systems (ISO
13485, ISO 9001,
ISO 14001, OHSAS 18001)
- Technical inspectironstatistical inspections,
inspection certificates
- Expert opinions
- PRODUCTS ASSESSED IN ITC ACCORDING TO the Council
Directive 93/42/EEC
Institute for Testing
and Certification, a joint-stock company is authorized by the decision of ?MZ (Czech
Office for Standards, Metrology and Testing) as the
Notified Body No. 1023 for conformity assessment of all medical devices
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