The Customer
A top 10 medical device manufacturer with a strong foothold in the cardiovascular and diabetes care market was looking for a partner who could help in the mitigation of the inconsistency of risk-related information in their product documentation through a systematic risk evaluation process (REP).
Challenge
The Solution: Regulatory writers and medical reviewers with MDD/MDR knowledge
- Indegene established a dedicated team of highly skilled regulatory writers and medical reviewers with deep domain and Medical Devices Directive (MDD)/Medical Device Regulation (MDR) knowledge to partner with the customer to establish a systematic risk evaluation process to document all product risk information in a Risk Evaluation File (REF)
- We identified geographic variability, product specificity, type of risk (contraindication-warning-precaution variability), and analyzed information for EU MDR specific sections – intended clinical benefit/critical warnings/notice on materials list/limitations/incident reporting
- Gap analysis done between IFU/FMEA (failure mode effected analysis) – map failure modes, and identify hazards, assign as warning/precaution based on severity and occurrence/probability rates
- We listed AEs from sources – IFU, CER, Clinical Study Reports (CSRs), literature articles, hazard analysis, FMEA, RMR, and competitor labels
- The output of the risk evaluation process was the REF, which ensured that the risk information was consistent and accurate across all upstream and downstream product technical documentation
Outcomes
Through the implementation of a systematic risk evaluation process (REP), Indegene was able to successfully address the customer’s challenge of inconsistency in risk-related information across various product technical documents. The customer was able to achieve a remarkable enhancement in the accuracy and consistency of risk information. Additionally, the streamlining of the documentation process and connecting critical functions like clinical evaluation, risk management, and post-market surveillance, ensured a comprehensive and unified strategy in managing product risks.
135+
REF and FAE generated annually
10%
Efficiency leveraging time zones and CoE model
30+
Products achieved EU MDR recertification
Discover how Indegene's proven systematic risk evaluation processes can optimize your medical device documentation. Contact us today to optimize your documentation and ensure regulatory compliance.