ISO 13485 Medical Devices

What is ISO 13485?

First published in 2003, ISO 13485 is the professional management standard for the design and production of medical devices. Dovetailing neatly into an organisations’ compliance with ISO 9001, this universally recognised international standard for the creation and manufacture of medical devices is accepted as the first step in attaining full compliance with wider European regulations - and gives your company the right to use CE Marking on medical equipment sold within the European Union.

Within this context, Hatton Parkinson Associates can assist your organisation in achieving compliance with ISO 13485 – often in tandem with its sister standard of ISO 9001.

The Benefits of ISO 13485

Achieving ISO 13485 certification signals your company’s desire to not only comply with relevant European Union law regarding the sale of medical equipment to member countries, but also shows your organisation’s commitment to high quality product design and manufacturing procedures and the ability to adhere to industry recognised management standards.

Being able to use the CE mark on your products also means your customers, staff and other stakeholders will more readily buy into the ‘quality first’ dynamic of your organisation, positively enhancing the client and employee interaction with your brand and helping the wider community to view your company in a more favourable light.

On top of this, our clients have found that achieving ISO 13485 certification helps them to streamline their daily operations to achieve greater working efficiencies, whilst simplifying management practices and making them more effective. You may also save money in gaining joint accreditation for both the ISO 13485 and ISO 9001 standards simultaneously.

Elements of the ISO 13485 standard

Certification for ISO 13485 means your organisation must demonstrate adherence to industry best practice through all stages of a product’s lifecycle, from concept and prototype to manufacture and maintenance.

The elements of ISO 13485 encompass:

Achieving ISO 13485 Certification

In order to gain certification to the ISO 13485 standard, you must have documented systems and procedures that comply with the Standard.  These must be audited by an accredited third party assessment body.  HPA only recommends using an assessment body registered with the  United Kingdom Accreditation Service (UKAS)