Koven cardiovascular innovation

Your Biomedical Design & Development Partner

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.

We can help with:

  • Quality Policy Development
  • Development of Standard Operating Procedures
  • Forms and Lists
  • Training and implementation support
Quality Management Services