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4th Annual Healthcare Division Reception at WCQI

The Healthcare Division invites its members and their guests to attend its 4th Annual Reception at WCQI on Monday, May 4, in the Bayou E Room at the Gaylord Opryland Hotel in Nashville, TN, at 7 PM. A presentation by Denis Romain, Chief Quality Officer, Mölnycke Health Care will be featured, followed by a reception and networking.

Presentation: The Collaborative Discipline of Daily Compliance Management

Mölnycke is a global manufacturer of products and medical equipment for the healthcare industry.  It is required to comply with both the pharmaceutical and medical device quality regulations of the United States as well as the requirements of all other nations where it wishes to do business. The total number of these requirements is in excess of 400, and they change dynamically on a regular basis.  The obligation of Mölnycke is to serve its customer with integrity in its management systems so that it may earn the trust of its global customer base.  This presentation describes the collaborative approach that Mölnycke has used toward its development of a company-wide system for daily management of its total compliance requirements.  Mölnycke calls this program Succeed.  The structure of Succeed as well as the practice that Mölnycke used for developing this methodology will be presented along with the current set of challenges and future extensions that are envisioned to maintain pace in a rapidly growing global industry that must remain robust in the face of dynamic changes in the regulatory environment.  This is the Mölnycke story of it persistent pursuit of ever-increasing quality as it learns to focus, simplify, and extend its current practices to attain its goal of become the most trusted healthcare provider in the world.

Speaker Biography: Romain Denis is the chief quality officer for Mölnycke Health Care, a medical device and pharmaceutical manufacturer with headquarters in Gothenburg, Sweden. He is responsible for directing the design and development of all company-wide quality practices; creating and implementing the manufacturing site certification strategy for environmental, health, and safety; managing the compliance with medical device and pharmaceutical standards; developing relationships with notified bodies in all nations of operation; and assuring that quality methods and information systems support the company-wide system.  The systems emphasis that unites all of these areas of responsibility is an integrated, compliance-based daily management system called “Succeed.”  Prior to his current assignment, Romain was the Quality Director for the Europe, Middle East, and Africa (EMEA) region of operations for Boston Scientific and the Quality and Regulatory Affairs Manager for Stryker Spine.  Romain holds degrees in mechanical engineering and bio-mechanical engineering with specialization in industrial quality, reliability and maintenance, and materials science.  He is a Senior member of the American Society for Quality.


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