• Implementation

    Our technical team will support you to implement Quality Management System according to the requirements of ISO 13485. Based on the size of organization, type of products, outsourced processes we will help you to implement an effective QMS and will capable you to obtain your ISO 13485 certificate.

  • Combination with MDR QMS

    Manufacturers who would like to obtain CE Certificate, need to implement QMS based on the requirements of EU MDR 2017/745. We will support you to upgrade your QMS from standalone ISO 13485 to combination of MDR & ISO 13485 to mee the EU Applicable Regulatory Requirements.

  • Outsource of Internal Audits and maintaining of QMS

    In Documedex, we can support you to maintain the effectiveness of your QMS with Internal audits, monthly meetings, frequent data analysis, reviewing your documents and records, updating you for the new regulations and applicable standards as well as supporting management team for continues improvement.

Contact us for any enquiries relevant to the Regulatory Pathway, EU MDR, QMS-ISO 13485, MDSAP, Technical Documentation, etc.