Real World Evidence (RWE) for Medical Devices
Real-world evidence (RWE) refers to data regarding the use, effectiveness, and safety of medical products (such as drugs, biologics, and medical devices) that is derived from real-world sources, including electronic health records, claims data, patient registries, and other healthcare databases. Unlike data collected in controlled clinical trials, RWE is generated in routine clinical practice and reflects the diverse patient populations, clinical settings, and healthcare delivery systems encountered in real-world healthcare settings.
Topics covered in this Whitepaper include:
- Importance of RWE
- Start to end regulatory submission process for medical device by using real world evidence
- How Real World Evidence Helps in Regulatory Submission Process in USA and EU
- How Real World Evidence utilized in regulatory approval procedures for medical devices
- List of countries which accept RWE in regulatory submissions
- Differences in length of regulatory approval process
