SIGMA CONNECTIVITY MEDTECH: ISO 13485:2016 certified by NQA

Sigma Connectivity MedTech has, during the winter, delivered a customer project where our quality management system has been used to show conformity towards ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.

As of 14th of May 2023 we are now ISO 13485:2016 certified by NQA:
“Provision of consultancy and quality assurance services within the fields of product design, product development, software development, industrialization and resourcing in medical devices”

We are proud to now be able to help our clients design and develop medical devices using our quality management system, which can be used stand-alone or as a complement to the client's quality management system.