CytoSwim Limited Achieves ISO 13485 Certification

BSI ISO 13485 Quality Management for Medical Devices logo BSI ISO 13485 Quality Management for Medical Devices logo

CytoSwim Limited a medical devices company developing technologies to enable Smarter Sperm Selection as part of the effort to combat male infertility, is pleased to announce it has successfully achieved ISO 13485:2016 certification.

This internationally recognized standard for quality management systems is specific to the medical devices industry and shows that CytoSwim Limited is committed to the highest quality of its company, products and services.

This is a crucial milestone for the company coming on the back of FDA clearance for its novel SpermAlignTM product earlier this year.

The excellence of design, validation and quality management systems are a testament to the focus on quality and hard work lead by Founder and Scientific Director Dr Max Meissner.

"We are very pleased to have achieved ISO 13485:2016 certification given the company profile," said Dr Meissner "This certification shows that the hard work, focus on customer satisfaction and design excellence and the safety and quality of our products and processes mean we can reliably meet customers' needs". Dr Chris Sheehan, Managing Director, also paid tribute to Mr Andrew Whitton at Insight Regulatory Consultancy and his team for guiding us through the process.

For more information please contact us.

Published