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    Achieving and Maintaining Regulatory Compliance is our speciality.

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    Tailored Solutions
    for your Regulatory

Auditing your own quality system is necessary to prevent quality and compliance issues. Auditing the quality systems of your critical suppliers, is the way to actively control their reliability, thus the constant compliance of your product. In 2019, the transitional period for updating QMS to ISO 13485:2016 will end.  Before updating the QMS, the first step is to perform a systematic gap analysis. The second step is to introduce the required changes in the quality system. At last, the internal audit is the method to verify the effectivity of the implementation of the changes. BioTop Medical offers all the steps leading to the update of the quality system.

Auditing requires extensive resources including an experienced “eye” to find possible non-conformities.

BioTop Medical offers to its clients:

  • Experienced auditors;
  • Independent assessment; 
  • Complete and clear audit reports; 
  • Advice on improvement actions;
  • Planning of the follow-up actions.