ISO 13485 Medical Device Auditing Service

  • We provide ISO 13485:2016 Medical Device Quality System auditing service.

    Our Auditor are selected among the most skilled experts and SMEs.

    We conducts fully independent quality system audit either for companies with ISO 13485 certification already in place or looking to prepare and get ready for the first ISO 13485 certification audit.

    Within our services:

    • Internal Auditing service according to ISO 13485:2016 combining on-site and remote
    • Third party manufacturer, supplier and service provider Auditing
    • Audit preparation and support for new certification or renewal
    • Gap Analysis to improve or challenge compliance

    Reach out to us to, write to info@tsquality.it or fill out the form on the side.

    Is your organization ready for a notified body audit, either scheduled or unannounced?

    The key to compliance is establishing a sound QMS which supports all the necessary requirements for documentation, adherence to all applicable regulatory requirements and standards, and continuous improvement through a review of post market information.

    This should all be established within the framework of a corporate culture focused on not only meeting, but exceeding customer needs and expectations.

    Is your Technical documentation and Quality System ready for the submission?

    Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that products meet the essential requirements of the Medical Devices Regulation (MDR), and other applicable regulations or recognized standards.  Initial device approval certifications will include a review of the company’s technical documentation, which may be a technical file for Class IIa and IIb devices, or a design dossier for Class III devices.   In addition, most manufacturers will also obtain a certification for their quality management system (QMS) in accordance with EN ISO 13485:2016.

    The notified body audit may encompass a review of both the QMS requirements and a review of the technical documentation for approval of devices or product families.  Initial review and certification may take one or more auditors several days to fully assess the level of compliance with the QMS and MDR requirements.  After certification, the notified body will schedule annual surveillance audits to monitor the on-going compliance and continuous improvement of the QMS.

    Do you need training to stay up to date?

    We offer flexible training program either in webinar or on-site mode. Reach out to us to arrange a session, write to info@tsquality.it.

     

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