Research Library

The top resource for free research, white papers, reports, case studies, magazines, and eBooks.

Share Your Content with Us
on for readers like you. LEARN MORE
The Regulatory Evolution and Data Revolution in Medical Device Development
Request Your Free White Paper Now:

"The Regulatory Evolution and Data Revolution in Medical Device Development"

Global Regulatory, Data Analytics, and Patient Centricity in Medical Device Development

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 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

Offered Free by: Medidata Solutions
See All Resources from: Medidata Solutions

Recommended for Professionals Like You: