ISO 13485:2016

ISO 13485:2016

ISO 13485 Quality Management for Medical Devices (MD), including in vitro diagnostic medical devices (IVD), across the entire supply chain.
Are you a provider of services such as sterilisation, reprocessing of medical devices, packaging of medical devices, development (including MD/IVD software), logistics, storage, distribution, disposal and recycling?
Are you a supplier, such as a manufacturer of raw materials (e.g. plastics, metals, chemicals) or a producer of electronic or mechanical components? Do you assemble IVD and MD treatment kits? Are you a Clinical Research Organisation (CRO)?

Even if you do not manufacture a finished medical device, you often have to comply with ISO 13485 requirements, as your components affect the safety of the end product. Do your partners require compliance with the ISO 13485 standard?
ISO 13485 is becoming increasingly important in the healthcare sector. In hospitals in particular, the standard is of great value for areas such as medical technology, the bed management centre and logistics, as its risk-based approach enables medical services to be supported smoothly in accordance with regulatory requirements.
Now is therefore the ideal time to take your quality management to the next level and make full use of the opportunity offered by ISO certification.
Implementing ISO 13485 enables your organisation not only to reliably demonstrate compliance with regulatory requirements, but also to proactively manage risks.
In doing so, you establish best practices for quality and safety, optimise your processes in the long term and build – as your most valuable asset – the essential trust of your customers.

The benefits of ISO 13485 certification for you:
With this management system, you credibly demonstrate to your customers, partners, staff and regulatory authorities that you take responsibility. At the same time, you document the outstanding quality of your services at an international level.

Get your information now
Whether it’s initial certification or recertification of an existing management system – QS Zürich Ldt. will guide you every step of the way. Contact us for a no-obligation initial consultation or use our enquiry form directly