We are pleased to announce that we have successfully passed our first stage ‘desktop’ ISO 13485:2016 quality management system audit of our procedures and processes with BSI and remain on track with our plan to become ISO 13485:2016 accredited
When it comes to medical device design and manufacturing, patient safety greatly depends on the quality and consistency of medical products. The ISO 13485 standard supports companies like us in designing a quality management system that establishes and maintains the effectiveness of our processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
Ensuring the effectiveness, control and maintenance of our QMS is critical to our customers, stakeholders, patients and users, and regulatory agencies.
Having our first audit has given us the opportunity to test the effectiveness of our quality management system and given us valuable feedback on how we can continue to improve both the system and our processes as we work towards our second stage audit and beyond.
Our goal of ISO 13485 accreditation will give us confidence in the ability to consistently achieve and maintain compliance with regulatory requirements and be another major achievement along our commercialisation road map.
Thank you to our employees and business partners who have helped us with this project so far, it takes a lot of time and hard work to set up and begin to implement a medical device quality management system. We now move into the full implementation phase of the project to prepare for the second stage audit. Watch this space for further updates!