Quantifying Risk in Various Methods of Continuous Monitoring

Worldwide, there is growing concern about how to protect public safety and increase cooperation among regulatory agencies to audit medical device companies and their suppliers. Regulatory agencies are increasingly looking to global organizations such as the Global Health Task Force (GHTF) to adopt harmonization in regulatory practices. As recent as August 2010, the GHTF made medical device suppliers inclusive of site auditing guidelines. (“A supplier delivering materials, components, or services, that may influence the safety and performance of the product.” GHTF/SG4/N33)