Full ISO13485 Quality Management System implemented
Full ISO13485 Quality Management System
Safety & Quality
Safety and quality are non-negotiable in the medical device industry, that’s why have implemented a full ISO13485 Quality Management System with full accreditation delivered in April 2021.
Regulatory requirements are increasingly stringent throughout every step of a products life cycle, including service and delivery. Increasingly organisations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical device industry.
Standards Required
If you are going to sell medical devices or PPE in the EU then implementing ISO13485 is still not enough to meet all of the legal requirements. With ISO13485 in place you will still need to meet the requirements of the EU Medical Device Regulation 2017/745 (EU MDR) and EU PPE Regulation 2016/425. The necessary mandatory requirements have been identified and incorporated into our QMS ISO13485.
So the overall objective is to manufacture a product that is manufactured, tested and regulated to the highest possible level.
Pressure controlled production environment.