04 Aug
|
Tata Elxsi
|
Telangana
04 Aug
Tata Elxsi
Telangana
Job description:
Thorough understanding of MDR
BEP, BER, CMR-ED, Gap Analysis of the existing documents, if any
Material Compliance
Key Responsibilities
Define and execute biological evaluation strategies per ISO 10993 and EU MDR.
Review material composition, supplier data, and existing biocompatibility evidence.
Prepare or update Biological Evaluation Plans (BEPs) and Biological Evaluation Reports/Biological Risk Assessments (BERs/BRAs).
Assess data gaps and recommend testing, literature review, or justification approaches.
Collaborate with Toxicology and Risk Management teams for integrated assessments.
Support responses to Notified Body queries related to biocompatibility.
📌 Biocompatibility Specialist Tata Elxsi, Bangalore/chennai/hyderabad/ Telangana
🏢 Tata Elxsi
📍 Telangana