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ISO 13485
ISO 13485 – Medical Devices

At each stage of your product’s life, regulatory requirements are scrutinized in the manufacture, delivery, or service stages. Laboratories and other organizations in your industry are expected to exemplify a sound Quality Management System (QMS) to demonstrate best practices.

Are you keen to ensure the devices in your medical laboratory are safe, effective, and delivered to a high standard? Do you want to be brought up to speed with national and global requirements for your industry? As a medical device manufacturer, the ISO 13485 standard is the most accepted global standard of its kind. If your business wants to put competency at the forefront of your operations, We can talk you through how this certification will improve and validate how you work.

What is ISO 13485?

Certification ensures that medical devices in healthcare settings are designed, produced, installed, and serviced to the highest standards. ISO 13485 originates from the need to meet client obligations and the regulatory and legal specifications for business owners involved in the manufacture of medical devices manufacturers.

Adopting the ISO 13485 standard into the heart of your practices means you will build a clear, practical foundation to address these specifications by taking control of your supply chain with a robust framework that will reduce costs. Your business will also demonstrate a commitment to safety, quality, and competence for medical device manufacturing, recognized worldwide.

Throughout the ISO 13485 certification process, you will be guided by a dedicated ISO consultant. They will start by assessing your business and then help you to use the results to improve your medical device manufacturing quality management system. We work with the senior management team to ensure the ISO 13485 standard framework is embedded throughout your organization before you are assessed by a third-party auditor who awards the certification.


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