ISO 13485 - Medical Devices Quality Managment System

ISO 13485 - Medical Devices Quality Managment System

The ISO 13485 standard requirements are the foundation upon which to build a robust quality management system. It is vital that all of the customer and regulatory requirements be met and monitored throughout the planning, design, manufacturing, and delivery process.

Our approach is to develop management systems for you where the quality is built-in, removing the necessity for separate management and quality systems. Our unique, integrated, implementation approach is to fuse business process management, performance management, and quality management systems, ensuring a single source of up-to-date knowledge and data that meets the requirements of management, staff, external stakeholders, and quality accreditation agencies. This approach is entirely consistent with the requirements for all recognized QMS accreditations. Working with senior management, we ensure the QMS delivers real, tangible benefits to your organization.

Through implementation of an ISO 13485:2016 compliant Quality Management System will enable your organization to identify risk relating to possible non-conformances and reduce or prevent costly incidents. Product non-conformances with medical devices could literally become a matter of life and death. Establishing a robust ISO 13485:2016 compliant Quality Management System is a powerful way to demonstrate your organization’s commitment to product quality. This may also enhance your public image, increase your brand equity and improve your market share. Implementing any new process or system requires commitment. Commitment of resources, time and at times capital investments.

Risk and quality management in one integrated system

As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, medical device companies must incorporate risk management processes throughout their business. Integrating risk management into your quality management systems is the optimal approach. If you already have an ISO 13485 or FDA QSR quality system, we can design and document a system for managing and evaluating risk that meets the requirements for ISO 14971.

At Maven, we have highly qualified consultants with experience in multiple industries ready to help assist your organization to develop a robust plan for the implementation of an ISO 13485:2016 certified Quality Management System.

Benefits of ISO 13485:2016 Consulting include:

  • Reduced QMS development and implementation time
  • Quicker path to ISO 13485:2016 certification
  • Improved effectiveness and efficiency of the QMS processes
  • Fulfillment of all legal and regulatory requirements based on your product’s classification
  • Development of a continual improvement culture within your organization



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