GxP and Medical Device Compliance Services

Medical Devices - QMS ISO:13485

We’ll implement an QMS ISO 13485 that ensures compliance with any regulations your medical device is subject to, while also helping you bring your product to market in less time and with less risk.



Quality Management Systems - Precondition for market approval

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the Health Canada Canadian Medical Device Regulations CMDCAS programme.


Although ISO 13485 certification is not a direct requirement for CE marking medical devices under the European Medical Device Directives, it is recognized as a harmonized standard by the European Commission. As one of the leading notified bodies for CE marking, we can support you on selecting the most efficient conformity assessment routes to achieve CE marking.

Consultys ISO 13485 Certification is one component of the comprehensive portfolio of quality management assurance services that we provide, together with our QMS Turn-Key Solutions.

What is an ISO 13485 Quality Management System?

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Increase access to more markets worldwide with certification

  • Outline how to review and improve processes across your organization

  • Increase efficiency, cut costs and monitor supply chain performance

  • Demonstrate that you produce safer and more effective medical devices

  • Meet regulatory requirements and customer expectations

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We’ll implement an QMS ISO:13485 that ensures compliance with any regulations your medical device is subject to, while also helping you bring your product to market in less time and with less risk.


Consultys Quality Management Services

Learn more how Consultys can support your organization in the implementation of QMS ISO 13485 in a lean and efficent approach.

ISO 13485:2016

QMS ISO 13485 Implementation

  • QMS development and implementation of a new QMS ISO 13485 System
  • Identifying processes and document it in procedural requirements (e.g. development, production, supplier control, CAPA, market monitoring, documents control, management review, etc.)
  • Policies and SOPs writing / development
  • Review and approval of technical documents
  • Preparation and negotiation of Quality Agreements
  • Execution of Internal Audits (internal and outsourced processes)
  • Quality Management System and Guideline Trainings / Workshops

QMS Improvments and Upgrades

QMS Improvments & Upgrades

  • QMS ISO 13485:2016 evaluating and improving existing quality manuals (Gap-Analysis, Implementation, Project Management)
    • e.g. adding missing content to achieve the standards compliancy
    • eliminating unnecessary requirements thereby purging quality manuals
    • redesigning processes in order to achieving the quality management goals: bigger success in the market with your high quality products and services
  • CAPA Management (Handling of CAPAs, Process Design and Improvments, CAPA Strategy Definition, day-to-day work)
  • Complaint Management (Process Design and Improvments, System Optimization, eComplaint Tools)
Supplier Audits and Inspections for Medical Devices

Supplier Audits / Inspections

  • Supplier Audits
    • External Supplier Audits
    • Stakeholder Coordination and Training
  • Inspection Preparation and Support
    • Internal Inspection Workshop
    • Inspection Simulation (mock)
    • Mentoring & support during Inspection
  • Post Inspection Support
    • Measurement plan (CAPA plan)
    • Monitoring and implementation of comitted actions
    • Official communication with authorities
    • CAPA Management