• English Services 01

    Achieving and Maintaining Regulatory Compliance is our speciality.

  • English Services 02

    Tailored Solutions
    for your Regulatory
    Needs.

The 2016 version of ISO 13485, is the latest revision of this recognized standard for the Quality Management System of medical devices companies in the EU and other countries. The standard describes the processes which should be in place for the design & development, manufacture, delivery and improvement of medical devices. The requirements of this standard are in line with those of the medical device regulations of the countries who adopted the standard.

BioTop Medical assists its customers in the set-up or upgrade, improvement and maintenance of the Quality System by:

  • Providing the necessary information and guidance;
  • Developing and implementing the system on a project basis, including the necessary training of the personnel;
  • Hands-on (e.g. drafting, reviewing quality documents) assistance to the QA-Manager with setting-up or upgrading the quality system;
  • Acting as the QA-Manager on an interim basis;
  • Sharing its experience with the QA-Manager;
  • Auditing the system and providing feedback for improvement;
  • Coordinating the changes for improvement.