ISO13485:2016 was published on March, 2016.
Focus as below :

Organizations can be involved in one or more stages of the life-cycle including the design and development, production, storage and distribution, installation, or servicing of a medical device and the design and development or provision of associated activities (e.g. technical support). This International Standard can also be used by suppliers or external parties that provide product including quality management system -related services to such organizations.

Risk Management > Design > Outsourced process > Suppllier Control > Feedback, Regulatory Authorities > Regulatory Requirements :  PDCA

Advisory notice

Authorized representative

Clinical evaluation



Implantable medical device



Life cycle


Medical device family 

Performance evaluation

Post market surveillance

Purchased product 

Risk management

Sterile barrier system

Sterile medical device

ISO 13485:2003, the internationally recognized QMS standard for the medical device industry, with over 25K certificates globally.

ISO13485:2016 provides an effective framework to meet the comprehensive requirements for a medical devices QMS; for manufacturers and service providers to both comply and demonstrate their compliance to compliance obligation.

ISO13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose. ISO13485:2016 is applicable across the whole supply chain and seeks to address the entire product lifecycle of a medical device.

ISO 13485:2016 are used by suppliers or other external parties providing products or services to medical device manufacturers. By using ISO 13485:2016, organizations will be able to demonstrate compliance with compliance obligation, risk base thinking, ensure best practice for quality and safety, and provide confidence to patients.

ISO 13485:2016 more focus on:

·       regulatory requirements

·       risk management and risk based decision

·       validation, verification, and design activities

·       Strengthening of supplier control processes

·       feedback mechanisms

·       More explicit requirements for software validation 


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