Maintenance of audit bodies on compliance assessment

According to the current legislation the estimation of compliance with Technical regulations for medical products, relevant to such categories as:

• According to Technical regulations concerning medical products (resolution of CMU №753):
  — Category I: Is (sterile); I with the functions of measurement,
  — Category II: IIа, IIb,
  — Category III.
• According to Technical regulations concerning medical products for diagnostics in vitro (resolution of CMU №754):
  — Products for diagnostics in vitro according to the categories “A” and “B” (reagents, calibrators, controls), products for self-control.
• According to Technical regulations concerning active medical products that are implanted (resolution of CMU №755):

  Supposes involvement of the body on compliance estimation and can be carried out by one of the following scripts:

  1. By means of compliance estimation of the quality management system at the production area (by means of inspection);
  2. By means of batch-by-batch estimation of compliance with the following issue of certificate for the definite batch (delivery) of medical products.

  Compliance estimation by means of inspection lets issue the certificate on the quality management system with the validity period of 3 years and the certificate of compliance for medical product with the validity period of 5 years, while batch-by-batch estimation needs repetition of procedure for each new batch, that doesn’t justify the cost of time and financial resources in most cases.

  The company 8L GROUP offers its services on maintenance as preparatory stage as the process of inspection of manufacture directly.

  Trust the process to the professionals, save your time and budgets for new opportunities!