May 2012 Posts

Medical Device Performance Is One Thing—Security Is Another

Mark Crawford

According to the Information Security and Privacy Advisory Board (ISPAB), federal agencies need to do more to protect the security of networked medical devices, such as wireless insulin pumps and pacemakers—including strengthening reporting methods for incidents.

The board sent a letter on March 30 to U.S. Department of Health and Human Services, National Security Council, Department of Homeland Security, NIST, and the U.S. Office of Management and Budget outlining key issues. (more…)

How Culturally Aware Are You?

Mark Crawford

Mark Hehlis president of Hehl & Associates (, a business improvement organization that provides cost reduction, quality improvement, sourcing, and training services to companies with international operations and/or suppliers. In the following interview, based on his extensive experience working in China, India, Malaysia, Thailand, Taiwan, Korea, Japan, the Philippines, Mexico, Ecuador, Brazil, and The Dominican Republic, Mark shares his insights on the importance of cultural awareness when doing business overseas. (more…)

New ISO Standard for Environmental Management Accounting

Mark Crawford

In the fast-paced world of high-tech manufacturing, it’s easy to get caught up in the quality and risk-management challenges of production, supply chain management, and regulatory expectations. Keeping costs down, however, gets harder to do as OEMs make more complex products, expect faster times to market, and demand more vendor services. (more…)

Notified Bodies and Clinical Evaluations

Mark Crawford

Nancy J. Stark is president of Clinical Device Group, a medical device clinical consultancy based in Chicago. Recently she has noticed an increase in requests for clinical evaluations and offers advice about how to write clinical evaluation reports to meet the requirements of notified bodies. (more…)