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Indegene

Indegene Accelerates Hazard Evaluation and Risk Analysis Process for over 50 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

Challenges

  • 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

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

100%

Compliance to ISO Risk Management Standards

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