• Annex 2 – Full quality assurance system (module H)
• Annex 3 – Type examination (module B)
• Annex 4 – Verification (module F)
• Annex 5 – Production quality assurance (module D)
• Annex 6 – Product quality assurance (module E)
Certification of medical products – our competence:
Within the scope of medical products covered by the following directives implemented into the Polish law:
Medical products:
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- Council Directive of 14th June 1993 on medical devices (93/42/EEC) with amendments
IVD medical devices:
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- European Parliament and Council Directive of 27th October 1998 on medical devices for in vitro diagnosis (98/79/EEC) with amendments
Active implantable medical devices:
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- Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC).
WECERT and PCBC are offical partner of National Medical Device Directorate IR. IRAN (IMED) :
Certification Programme
As part of our activities, we certify medical devices based on the following attachments and accreditation area
Contact US and get a Quote
Medical Device Department
Product Certification Department