The life sciences and healthcare industries are going through a period of unprecedented regulatory change impacting pharmaceuticals, medical devices, in-vitro diagnostics and healthcare organizations for the benefit of patients. The ability to respond to regulatory requirements swiftly, effectively and efficiently is vital to a company’s reputation and viability commercially. This paper looks at the current, dynamic regulatory landscape within the medical devices sector and some of the current and future changes medical device organizations will need to adhere to.

1. The International Regulatory and Standards Landscape
2. United States Medical Device Development – Regulatory Process Summary
3. European Union Region Regulations
4. Revised ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice
5. Regulatory Common Themes – It is all about data!
6. Making this a Reality with Medidata
7. Summary – A Bold New World