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ISO 13485:2016: Medical device design controls and why they’re important

Medical device design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements. The ISO 13485 Certification is based on the quality management system, which helps to implement the medical device preventive system. 

Good design controls are important to:

·        Reduce product risks

·        Demonstrate your product is fit for purpose

·        Align your organisation

 Prepare procedures for design and development:

Document Manager enables you to prepare ISO 13485 procedures for design and development. So a Procedure is a high-level SOP and a work instruction is more for deep dive, and controlled documents. Under the requirements of ISO 13485, there are certain procedures that must be part of your QMS. Note which items ISO 13485 focuses on and ensure they're part of your plan while keeping the unique needs of your organization in mind.

ISO 13485 include a quality manual and various documented procedures, and add further documentation as needed. Be sure to include all documentation requirements in your implementation plan.

Design and development planning:

Document Manager enables you to:

·        Plan and control product design and development.

·        Document needed resources

·        Retain and maintain planning documents.

·        ISO 13485 Document the design and development stages.

·        Document responsibilities and authorities for design and development.

·        Document the methods to ensure traceability of outputs.

What are the Benefits of ISO 13485 Implementation?

The ISO 13485 emphasizes risk management, risk-based decision making and changes related to the increased regulatory requirements for organizations in the supply chain. 

·        Increase access to more markets worldwide with certification

·        Enhance credibility and recognition of your organization 

·        Improve decision-making processes 

·        Consistently improve your quality and performance 

·        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 


john Smith


ISO Documents Consultant

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