Archimedic Quality Statement

We take quality seriously and hold ourselves to a rigorous standard in all that we do.

Archimedic is committed to assisting clients with the development of safe and effective medical devices.

Quality System

Our commitment to excellence is reflected in a robust Quality Management System (QMS) compliant with 21 CFR 820 FDA Quality System (QS) Regulation and ISO 13485:2016.  This certification is a testimony to our commitment to providing the highest quality Design & Development services.

Our Waltham, MA site is ISO Certified. Our Newtown Square, PA site is planned to be certified in 2020. Download our ISO 13485 Certificate here.



Archimedic’s quality system allows for flexibility in our approach to each project. As an alternative to utilizing our internal quality system, our team can work within your quality system when requested.