“To get the ISO13485:2016 certification requires that you have a quality management system in place that guides you through the execution of the development project. The most essential are the procedures and guidelines related to requirements management, change management and risk management. These support in reaching the regulatory compliance and thus safety of the end results”, says Mikko-Matti Kukkonen, a project manager at Etteplan with an extensive experience in medical technology projects. “And a good quality system also speeds up the development work”, Mikko-Matti adds.
“With ISO13485:2016 certification our customers do not necessarily need a full-fledged quality system of their own. This makes product development easier for smaller companies and start-ups. Our updated quality management system also makes it easier for us to participate in larger product development programs, where all the parties need to be certified” explains Antti Tolvanen, Sales Director for MedTech at Etteplan.
Etteplan provides mechanical, electronics and firmware design, cloud and mobile applications, regulatory compliant technical documentation including manuals and labelling, tester development and laboratory services for medical technology industry.