We are pleased to announce that LindaCare is now ISO 13485:2016 certified for the design and development of our software which translates to more consistency, less risk, and continued quality for LindaCare partners.
Successful partnerships rely on quality and consistency every step of the way. Our certification of the highest level for the medtech industry, ISO 13485:2016, offers another reason to count on LindaCare.
What is ISO 13485:2016?
The certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical device related services that consistently meet customer and applicable regulatory requirements.
What will this mean for LindaCare Partners?
In the face of increasingly complicated regulatory hurdles, the certification for ISO 13485:2016 reinforces LindaCare’s commitment to the medical organizations we work with every day.
As your monitoring partner we’ve upgraded our quality management system to reflect the latest requirements in design and development of remote monitoring software continue to offer high-quality services—all to help our partners reduce risk and improve patient outcomes.
“Our focus on quality and compliance is a cornerstone of LindaCare’s business model, pushing to meet and exceed industry standards as a supplier,” says Shahram Sharif, CEO and Founder of LindaCare. “LindaCare continues to lead the industry and earning this mark is another outward example.”
LindaCare’s Quality Regulatory Compliance Manager, Frédéric Heraly said, “We are very proud of this certification. It demonstrates the commitment of all employees to quality, and to meeting customer and regulatory requirements.”
To find out more about LindaCare’s commitment to quality management, contact us here.