We are now an ISO 13485:2016-certified organization.
This key medical device development certification means our quality management system—which oversees its facilities, staff, and processes—complies with FDA guidelines. We meet all the requirements for designing medical devices for our industry-leading clients.
The certification is a testament to the quality procedures we’ve put in place for our clients, who trust our multidisciplinary strategy, design, and engineering teams with some of the most innovative and complex medical device design projects in healthcare.
While we’re insanely proud of our team, we’re even more excited for what the certification means for our clients going forward.
The certification will enable clients to:
- streamline their supplier certification process, laying the groundwork for a successful FDA submission;
- utilize our design control process while theirs is still under development.
We have been and continue to be committed to working in accordance with FDA regulatory requirements, and now with ISO 13485:2016, as well.
Our focus on quality over the years has resulted in high client-satisfaction ratings, as well as significant innovations in strategy, design, and engineering that have revolutionized businesses and enriched lives.