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.
The International Regulatory and Standards Landscape
United States Medical Device Development – Regulatory Process Summary
European Union Region Regulations
Revised ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice