Accreditation of medical laboratories


Certificates for medical devices.

Only accredited laboratories and certification authorities are allowed to check and certificate under prescribed laws or regulations.
Laboratories carrying out conformity assessment procedures in areas regulated by law, can be reported to the Commission of the European Community as a notified authority.
Accreditation arguments:

  • Confirmation of competence
    Die Akkreditierung bestätigt die Kompetenz Ihres Laboratoriums nach international anerkannten Richtlinien durch eine unabhängige Institution. The accreditation confirms the competence of your laboratory in accordance with the internationally accepted guidelines by an independent institution.
  • Confidence
    The confirmation of conformity with the accreditation requirements is the basis for mutual recognition of test reports, calibration results and certificates for products.
  • Comprehensive for all audiences
    The objective recognition of a laboratory by an independent authority provides security and recognition by manufacturers, consumers , laboratories and test authorities themselves

Our Services

  • Definition of the legal and normative regulations for your scope
  • Summary and implementation of the criteria for accreditation
  • Preparing your laboratory for the accreditation according to the applicable guidelines, laws, regulations and standards
  • Validation of test methods; particularly nonnormative procedures elektion geeigneter Akkreditierungsstellen Selection of appropriate accreditation bodies
  • Procedures, formalities and communication with government institutions
  • Process procedures and checklists, computer-assisted process procedures for medical and biomedical laboratories
  • Preparation of the necessary documentation according to accreditation guidelines, and conformity assessment by the accreditation authority
  • Laboratory manuals
  • Conducting internal audits and support for the accreditation audit
  • Network partners for physical, chemical and biomedical tests
  • Requirement profiles and individual training for security representatives, internal auditors, QM representatives


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