• English Services 01

    Achieving and Maintaining Regulatory Compliance is our speciality.

  • English Services 02

    Tailored Solutions
    for your Regulatory

Auditing your own quality management system is necessary to identify problems or potential problems, and to prevent quality and compliance issues. Auditing the quality systems of your critical suppliers, is a way to actively control their reliability, and therefore, the constant compliance of your product. Regulatory changes often lead to the necessity of updating the quality system. QMS updates are best performed when they are planned. The first step is to perform a systematic gap analysis. The second step consists in implementing the required changes and finally, the internal audit is the method to verify the effectivity of the implementation. BioTop Medical offers all these services; from the gap analysis to the audit.

Auditing requires extensive resources including an "experienced eye” to identify non-conformities and potential nonconformities.

BioTop Medical offers to its clients:

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