We are proud to announce that we have received SS-EN ISO 13485:2016 certification for Consultancy services focused on Quality Assurance, Regulatory Compliance and Design & Development for MD (medical device).

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. 

“An important milestone in our company’s history.”

– This is an important milestone in our company’s history. It has always been our plan to get this certification but to manage this within our first year as a company is beyond our expectations. Very grateful, extremely impressed and proud of what the team has accomplished, says Petter Arlehed, CEO at Yallow Life Science.

This certification confirms our competence in delivering core quality and regulatory services for medical devices according to internationally recognized standards. It positions the company as a trusted design and development partner.

“This means we are a trustworthy and reliable partner.”

– This means we are a trustworthy and reliable partner that can deliver compliant services. Of course, it is a benefit for our customers. Yet another proof of our high quality services within medical device development, says Ira Sharma Sankhayan, CCO at Yallow Life Science.