ISO 13485:2016

Quality management system for medical devices
Are you a supplier to medical device manufacturers? Do your customers and other third parties require you to fulfil the ISO 13485 quality standard? If so, you will have to deal with the implementation of this standard.
By applying ISO 13485, organisations are able to demonstrate their compliance with regulatory requirements, manage risks and ensure best practice to promote quality and safety, Ensure best practice to promote quality and safety, improve processes and ensure patient confidence.
Your added value with ISO 13485 certification: it shows your customers, partners, employees and authorities that you are taking responsibility with this management system.
You document the quality of your work on an international level.