CorFlow’s ISO 13485:2016 Quality Management System Certified by BSI

Baar, Switzerland, September 12th 2017

CorFlow Therapeutics AG today announced that its ISO 13485:2016 compliant Quality Management System (QMS) has been certified by the British Standards Institution (BSI). BSI is one of the leading European Notified Bodies for Class IIb/Class III medical devices and will support CorFlow during it’s European regulatory activities.

Blathnaid Feldman, CorFlow’s VP of Quality and Regulatory Affairs, commented: “The CorFlow QMS has been developed to support all product development and clinical activities in the company. In addition to being compliant with the European ISO standards, the system has been designed to comply with US FDA requirements according to 21 CFR 820. To have a QMS established and certified is quite unique for an early stage medical device company like CorFlow. ISO 13485 is the world’s leading medical device standard, and we have demonstrated that our QMS meets the more stringent requirements of the 2016 revision which places a greater emphasis on regulatory requirements and a risk based approach.”

The scope of the quality system is “the design, development, production and distribution of consoles and software systems, and associated medical device accessories used for diagnosis and treatment in coronary applications. Device installation and servicing”. This wide scope enables CorFlow to execute on all product development, clinical trials, manufacturing and distribution activities in order to bring safe and effective medical devices to the European market and later to the US and other international markets.

Jon H. Hoem, CorFlow’s CEO and Co-Founder, said: “A certified ISO 13485:2016 QMS is a major milestone for CorFlow. We are very pleased to reach it inside our ambitious milestone plan and we are committed to fulfil current international quality requirements so that CorFlow brings safe and effective devices to market.”

The CorFlow Controlled Flow Infusion (CoFITM; pronounced “coffee”) System consists of a Class IIb console and Class III catheter under the current Medical Device Directive (MDD) and will be classified as a Class III medical device under the new Medical Device Regulation (MDR).

The QMS = The Soul of a New Medical Device

In his non-fiction book “The Soul of a New Machine” (1981), Tracy Kidder describes the experiences of a computer engineering team racing to design a next-generation computer at a blistering pace under tremendous pressure.
A running theme in the book is the tension between engineering quality and time to market: the engineers, challenged to bring a minicomputer to market within a very short time-frame, are encouraged to cut corners on design and development activities.

Contrary to this approach, medical devices like the CorFlow CoFITM System, have to be developed using a structured QMS avoiding cutting corners to bring the devices to market and into clinical practise. A certified quality system ensures that no corners are cut and that the devices undergo rigorous testing before used in man. In many ways, the “Soul” of a new medical device comes from the structure of the quality system. CorFlow’s certified QMS is a central component to guarantee long-term compliance with international medical device standards. The quality system also ensures that data generated by the devices are reliable and can be published.

The true art in current medical device development is to combine a rigorous quality system with a lean approach to generate non-clinical and clinical data. The CorFlow team works diligently to deliver on this demanding combination.

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