Risk Information Inconsistency- Multiple and varying sources of risk information-Instruction For Use (IFU), labels, Risk Management File (RMF), Clinical Evaluation Report (CER), Technical Dossier, patient guides, patient leaflets, etc.
Inadequate Data- Limited availability of anticipated/observed Adverse Event (AE) data to identify new risks
Process Silos- Different functions like quality, clinical, and regulatory managing risk related information without connecting the dots between critical processes like clinical evaluation, risk management, and post market surveillance
Increased Deficiency Reports during Notified Body reviews due to variations and inconsistency in risk information across various product technical documents like IFU, labels, patient guides, patient leaflets, CER, RMF leading to delayed regulatory approvals
Established a team of experienced regulatory writers and medical reviewers with specialized knowledge of MDD/MDR regulations to help customers document product risk information in a systematic manner
Templatized the risk evaluation file and assimilation process
Gap analysis done between IFU /FMEA (failure mode effected analysis) - map failure modes, identify hazards, assign as warning/precaution based on severity and occurrence/probability rates
Listed AEs from various sources – IFU, CER, Clinical Study Reports (CSRs), literature articles, hazard analysis, FMEA,RMR, and competitor labels.
Analyzed AE sources for AE frequency rates
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
Increase in global product risk evaluation and assimilation process
Annually generated Risk Evaluation Files (REF) & Frequency of Adverse Events (FAE)
Vascular Products achieved EU MDR recertification from BSI