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ISO 13485 : 2016 Certification
Medical Devices


ISO 13485 : 2016 Certification

Quality Management System for Medical Devices

ISO 13485 in the United Kingdom, London, Manchester, Birmingham, and Glasgow

ISO 13485 is an international standard for quality management systems designed primarily for medical device manufacturers. It specifies a complete set of standards for medical device design, development, manufacture, storage, installation, and maintenance.

What is ISO 13485?

Medical Device Quality management system certification shows consumers, regulators, and other stakeholders that a medical device manufacturer’s quality management system satisfies the highest quality and safety criteria.

The advantages of ISO13485  certification in the United Kingdom, London, Manchester, Birmingham, and Glasgow

Frequently Asked Questions:

Although ISO 13485:2016 certification is not required, it does bring your practices up to speed with standard standards that exist throughout the country, the EU, and worldwide, which may be required in the future.

Companies that manufacture medical devices frequently discover that skilled consultants assist them in quickly adopting ISO 13485:2016 into their core procedures.

Our specialists at Universal ISO work directly with you to guarantee that your QMS is effective for your firm. We assist you in designing your control needs in accordance with the standard, and then submit them to a recognized, third-party certification organization, which will audit your company and certify it as ISO 13485:2016.

The time it takes to get ISO 13485:2016 certification is determined on the size, nature, and complexity of your firm. It is predicted that organizations with fewer than 50 workers would need 6-8 weeks. It may take 10-12 weeks for larger firms due to the time-consuming nature of complicated production procedures such as sterilization.


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