P1vital Products Ltd obtains ISO 13485:2016 certification!
We are proud to announce that P1vital Products Ltd has obtained certification ISO 13485:2016 for design, development, manufacture and distribution of software medical devices.
What is the ISO 13485 standard?
The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organisations involved in the Medical Device industry.
Is ISO 13485 recognized worldwide?
ISO 13485 Standard focuses on the harmonisation of the Quality Management Systems in the framework of Medical Device regulatory requirements. Many country jurisdictions recognise, or even require, that Medical Device manufacturers obtain ISO 13485 certification in order to access their market.
ISO 13485:2016 certification demonstrates P1vital Products Ltd’s commitment to achieving the highest quality medical device software and meeting customer and international regulatory expectations.