Life Sciences Insurance

Life Sciences Insurance

Comprehensive coverage supporting innovation while managing regulatory, product liability, and supply chain risks in healthcare and biotech.

Overview

India’s life sciences sector is undergoing a technology-led transformation. Medical devices, diagnostic platforms, AI-enabled health-tech systems and biotech innovations are redefining how healthcare is delivered — from surgical suites to remote villages. The convergence of hardware, software and biology in this sector creates a risk landscape that is as complex as it is consequential.

MedTech companies face rigorous regulatory pathways — including CDSCO device approvals, BIS certifications and international standards such as ISO 13485 and IEC 62304 — while managing product liability for devices implanted in or used on patients. Diagnostics businesses must protect against laboratory errors, reagent failures and data integrity breaches. Health-tech platforms handling electronic health records (EHR), remote patient monitoring and telemedicine services face acute cybersecurity and data privacy exposure. At the same time, biotech innovators must safeguard intellectual property and manage the liability arising from novel device-based therapies.

At Edme, we understand that this industry sits at the intersection of engineering precision, regulatory rigour and human consequence. We bring the specialist expertise, global market access and claims capability to protect MedTech, diagnostics, health-tech and biotech device companies at every stage of their growth.

The Edme Edge

  • Medical Device Product Liability Specialists
  • Regulatory Pathway Expertise
  • Cyber & Data Privacy Coverage for Health-Tech Platforms 
  • IP Protection for Biotech & Diagnostics Innovators 
  • Supply Chain & Business Interruption for Medical Devices
  • Access to International MedTech Underwriters 
  • Directors & Officers and Management Liability 

FAQs

  • Product Liability & Device Failures: Malfunctioning medical devices, implants or diagnostic equipment leading to patient injury claims and costly recalls
  • Regulatory & Certification Risks: CDSCO, ISO 13485, BIS and international device approval failures, inspection findings and market withdrawal orders
  • Cybersecurity & Data Privacy: Breaches of EHR systems, telemedicine platforms and connected medical devices exposing sensitive patient data
  • Intellectual Property Disputes: Patent challenges and unauthorized use of proprietary MedTech innovations, diagnostic assays and device designs
  • Supply Chain Disruptions: Shortages of critical medical components affecting device production and distribution continuity

  • Product liability and recall insurance: Covers financial losses from defective medical products or equipment failures and the cost of device recalls
  • Cyber risk insurance: Protects health-tech platforms against data breaches, ransomware and cyber threats affecting digital health services and patient records
  • Professional Indemnity Insurance: Safeguards against regulatory claims, inspection-related penalties and professional negligence in device design or certification
  • Business Interruption & Supply Chain Insurance: Mitigates financial losses from disruptions in medical device manufacturing and distribution

Talk To Us

Contact us to get in touch with an industry or risk subject matter expert, learn more about a specific solution or submit a sales/RFP inquiry.

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Disclosure

EDME INSURANCE BROKERS LTD. (FORMERLY KNOWN AS ADITYA BIRLA INSURANCE BROKERS LTD.)

Registered Office: 2nd Floor, Privillion, East Wing, Sarkhej - Gandhinagar Highway, Vikram Nagar, Bodakdev, Ahmedabad, Gujarat 380054. IRDAI License Number: 146 | Composite Broker | License Valid till: 9th April, 2027 | CIN: U99999GJ2001PLC062239 Corporate Office: VIOS Tower, 6th floor, Off Eastern Express Highway, Sewri - Chembur Rd, Mumbai – 400037 Telephone: 1800 120 2510 | Website: www.edmeinsurance.com In case of any queries/complaints/grievances, please write to us at care@edmeinsurance.com.