Medical Device QMS

What is Medical Device Quality Management System (MDQMS)?

Medical Device Quality management System (MDQMS) is a Quality System which focuses on the Medical Device design, manufacturing, service provision as per ISO 13485. the Medical Device QMS provides an assurance program to Company and medical industry ensure the product has been made to the high quality standard and all relevant regulatory compliances are met

IntegPro’s ISO 13485 consultants:

IntegPro has competent experts who can design and implement ISO 13485 QMS step by step including:

  • define the Scope,
  • design processes and QMS Structure,
  • develop QMS Documentations Including Quality Manual, Quality Policy, Quality Procedures, etc.,
  • train processes owners,
  • implement the processes and create records,
  • conduct internal audits and management reviews,
  • monitor Non Conformities, Corrective Actions Preventative Actions (CAPA),
  • support during ISO 13485 certification Audits.

The Benefits of ISO 13485 for Medical Device Manufacturers:

Medical Device manufacturer which is certified to ISO 13485 will gain access to the market and compete with competitors, regional market requirements.

ISO 13485 QMS demonstrates the commitment to relevant interested parties including customer to shows the Quality is the core of the business.

ISO 13485 QMS demonstrates compliance with relevant regulatory requirements such as FDA (USA), CE (Europe), TGA (Australia) etc.

ISO 13485 certification provides Verification of the conformance to ISO requirements as well as applicable Regulatory requirements as defined in the QMS.

IntegPro’s Role:

IntegPro designs and builds QMS processes as per ISO 13485 and regulatory requirement with the concept of Plan-Do-Check-Act cycle. The system can be designed traditional paper based or fully robust eQMS by using trusted and verified eQMS Software. The service includes Document Management, Training Management, Quality Event Management, CAPA Management, Change Management, Complaint Management, Audit Management, Supplier Quality Management, Risk Management, Design Control, Deviations/Non-conformances.