Full ISO13485 Quality Management System implemented.
Full ISO13485 Quality Management System implemented.
Full ISO13485 Quality Management System
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 expected 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 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). 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 and tested to the highest possible level.
- Tested in accordance with EN14683 2019 + AC 2019 for the European market and ASTM F2100-19 for the US Market.
- In accordance with Medical Device Regulation (MDR) European Union (EU) Regulation 2017/745
Pressure controlled production environment.