When creating a successful medical product, additional steps are needed to set up and maintain quality systems to meet regulatory requirements. We have extensive experience setting up quality systems for medical devices.
Quality System: “A set of processes and procedures you define and implement to describe how your company addresses medical device regulations, including design controls.”
FDA defines the rules in 21 CFR Part 820
. These regulations are required if a medical device is for the U.S. market. European requirements are a little different. Over there, a quality system be established to meet the medical device regulations (and/or IVD regulations). For this reason, many medical device companies decide to implement a quality system and have it certified to ISO 13485:2016 to fulfill EU requirements.
These are the medical device quality systems that must be put in place before clinical trials:
Document Control & Records Management