Do you want clean cut quality policies and objectives, while maintaining customer satisfaction and meeting regulatory requirements?
Our team can help you build a Quality Management System that will comply with the medical device regulations unique to your business.
We have the knowledge and expertise required to handle aggressive timelines and develop a complete Quality Management System so you are prepared to take your product to market.
Koven can deliver a QMS that complies with ISO 13485:2016, US FDA current GMP including 21 CFR part 820, and Health Canada medical device regulations.
We offer tailored pre and post-market QMS solutions.
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