Regulatory Working Group

Charter

Clarification and description of interoperable devices functions in a regulatory environment.

Scope includes both pre-market and post-market.
Scope includes international regulatory bodies:
- FDA
- Health Ministry of Japan
- EU member states
- Health Canada
- Therapeutic Goods Administration (TGA Australia)
- And others
Investigate official approaches to clarifying regulation of interoperable devices (Could be 513(g). Could be form 3429. Could be a white paper. Could be some other process yet to be determined.)

Educate and socialize the FDA and other regulatory bodies on Continua and interoperable devices.

Education and helping each alliance company. Which could include:

Testing and certification tools.
Shared resources.
Shared documentation and risk analysis.

Coordination with other Continua Working Groups and providing input as appropriate.

Join

If you are interested in joining the Regulatory Working Group please click here and follow the join group link.

Chair

Horst Merkle

Director, Information Management Systems Diabetes Care,
Roche Diagnostics Corporation

Horst Merkle has served as the Director of Information Management Systems, Diabetes Care since 2003. In this position he is responsible for the proposal and the development of key components for the Roche Diabetes Care information management product portfolio with focus on interoperability/connectivity, tele-health and standardization.

This position interfaces with all global and regional functions within Roche Diabetes Care business.
From 1999 to 2003 Horst Merkle was Senior Manager and Director of Business Development Near Patient Testing. This position involved Roche Diagnostics' accountablilty for the development of new business models and platforms for de-centralized and near patient testing in the hospital critical care environment.

Between 2000 and 2003 Horst served on the executive committee of the Connectivity Industry Consortium (CIC). The CIC developed the accredited POCT-1 standard for Point-of-Care systems interoperability.
From 2001 to 2004 he was a member of "Deutsches Institute für Normung" (German National Standard Organization) special interests group "Medical" called "NAMed".

Although a native of Germany, he has spent most of his professional life in Global Marketing, business and product portfolio development positions. Horst has been living in the United States since 1997 interrupted by a 2 year engagement in Mannheim Germany. Before moving to the USA he worked for 5 years as the Global Marketing and Portfolio Manager for AVL Medical Instruments in Switzerland. Focus: Critical Care analysis and information management.