Compliance to standards like ISO 13485:2016 is essential to medical device development. It requires focused attention to details and processes. The key to our clients’ success is collaboration with a team who has been there and done that in the regulated software space. Full Spectrum Software has a well-established Quality Management System (QMS) and has been ISO 13485 certified since 2009. Thanks to our matured QMS, we were able to help our clients obtain FDA approvals within record times!
Our standard operating procedures and templates provide the framework for compliance with all applicable international standards, including:
When our clients do not have their own QMS or one that includes software, Full Spectrum’s QMS provides all of the tools necessary for the complete software development lifecycle, and your Full Spectrum Software team will deliver a professionally-packaged Design History File. When our clients do have their own QMS, our team is also well-versed in working within the clients’ QMS environments.
Every project is unique. The particular processes and deliverables used in any project depend on the scope, magnitude, and safety classification of the product. Your Full Spectrum Software team will help lay out a plan to work within an ISO 13485:2016 compliant framework to: