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Streamlining Hazard and Risk Analysis: Indegene's Approach for 50+ Medical Devices​

The Customer

A multinational pharmaceutical company known for developing and manufacturing a wide range of innovative drugs and vaccines, have been exploring solutions for Hazard Evaluation and Risk Analysis to ensure the safety and efficacy of their products, as well as to comply with regulatory requirements


  • A recent acquisition by a first-tier medical device company resulted in a huge repository of medical devices for which remediation of risk files was required​

    Impending audit identified several improvement initiatives that required implementation.​

    The risk files required alignment with internal risk management protocols along with compliance to ISO 14971:2012 and ISO 13485:2016.​

The Solution: Developed hazard analysis listing templates across all product categories

A core SME team from Indegene brainstormed and collaborated with the clinical and safety experts from the client’s team

Hazard Analysis Listing templates were developed for product categories with substantial number of products within its portfolio​

Identified/modified hazards, hazardous situations, and harms for each device​

Provided MedDRA terminologies for harms, Coding them for the standardised Verbatims​

Utilized multiple sources of data for calculation of P2 (MAUDE, FAERS, internal complaints and AEs, clinical literature via search in PubMed and Embase)​

Rigorous weekly touchpoints with clinical and safety experts for resolution of queries

Outcomes: 100% Timelines Met & Compliance to ISO Risk Management

With Indegene's solution, the customer successfully streamlined the approach to hazard evaluation and risk analysis. This resulted in achieving a 100% adherence to timelines, ensuring a comprehensive risk assessment for full compliance with ISO Risk Management Standards for over 50 devices.


Timelines met


Compliance to ISO Risk Management Standards

Ready to accelerate hazard evaluation and risk management in your organization? Contact us now to explore innovative solutions tailored to your unique needs.

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