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ISO 13485

ISO 13485:2016 + A11:2021 is the International Quality Management Standard for Medical Devices.

What Is ISO 13485?

ISO 13485 is the internationally agreed standard for quality management of medical devices. This standard helps various organisations across the world that produce medical devices ensure their products are satisfactory.

The quality management standard for medical devices is designed for various industries and organisations to prove they are committed to producing quality products.

Achieve ISO 13485 Certification Using Mango Software

Do You Need A Copy Of The Standard?

How To Get Certified To ISO 13485

If you need assistance in getting certified to ISO13485, fill out a request a demo form. 


The team at Penarth will then determine which consultancy package or software is right for you in order to ensure you get certified to ISO 13485. 

Benefits of ISO 13485

Customer satisfaction and assurance

Increased risk management

Improve relationships with stakeholders

Ability to win more business

Meet legal requirements

Operational efficiency

Why Implement ISO 13485?

The medical profession is coming under increasing threat of legal action from those they treat. ISO13485 was introduced in order to provide a systematic method for the design and use of medical devices.

Implementing ISO 13485 will not only mean that you demonstrate a commitment to producing quality products, but you will also show that you meet legal requirements. 

ISO 13485 is compatible with many of the other ISO standards, such as ISO 9001 (quality management) and will provide an extra layer of reassurance to the global medical industry. 

Who is ISO 13485 Applicable To?

If your organisation operates under any layer of medical device manufacturing or pharmaceutical supply chain then ISO 13485 can be beneficial to you. 

Being certified to ISO 13485 is especially helpful for businesses that manufacture these products and need to prove that they meet legal requirements. 

ISO 13485 will also help with product traceability and recall systems, which is extremely important for these devices which are being used across the medical industry every day. 

Medical Devices Management Compliance Software

Use Mango to look after the standard activities of Medical Device Manufacturing, including:

Monitor the effectiveness of your quality system in real time

Document related policies, procedures and forms and then link them to other modules

Help your employees understand quality in an integrated way

Conduct real time non-conformance investigations from anywhere around the world

Prove to auditors that you are conforming with the requirements of the standard

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