Planet Innovation has a rigorous quality system that is certified to ISO 9001 and ISO 13485:2016 for development and manufacture of medical devices.
Our quality system includes formal stage-gated hardware and software development processes that include reliability as a key subsection.
We have a formal risk management procedure that we follow on all projects, as well as actively used templates for Failure Mode Effect & Cause Analysis (FMECA) and reliability management.
We have extensive experience developing biomedical devices for regulated US and European markets, including FDA QSR 820.30 Design Controls for Class II and III devices. Many of our staff have over 20 years experience working with organisations operating under FDA design controls dating back to the 1990’s.
We have a dedicated quality department and a comprehensive quality system including a QA manual, formal quality procedures for all major components of the development process and many templates and guidelines for development procedures and processes that we call on during every project.