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Medical imaging equipment room representing biomedical engineering professional liability

Biomedical Engineer PI Insurance

Professional Indemnity coverage for medical device design, clinical equipment, and healthcare consulting. Protection that understands the patient safety implications of your work.

$20M

Liability Limits

Specialist

Markets

Same Day

Quotes

Recognition

Industry Awards

Biomedical engineering directly affects patient outcomes. When medical devices malfunction, implants fail, or clinical equipment underperforms, the liability exposure includes both financial loss and patient harm.

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The Challenge

Biomedical engineers work at the intersection of engineering and medicine, where errors can harm patients. TGA regulation, clinical trials, and the litigious nature of healthcare create a demanding liability environment for anyone providing engineering consulting services.

Our Approach

We access insurers who cover healthcare technology and medical device regulation. We work closely with you to understand your specific activities and source professional indemnity cover that reflects the patient safety implications of your work.

WHY TANK INSURANCE

What to consider for PI cover

Biomedical engineering combines engineering precision with healthcare liability. Your PI insurance needs to address both the technical and clinical dimensions of your work.

Biomedical laboratory with scientific equipment representing medical device and healthcare technology consulting

01

Patient Safety Exposure

Biomedical engineering errors can have patient safety consequences. We work with specialist underwriters who understand the heightened liability exposure that comes with healthcare technology work.

02

Regulatory Consulting Risk

TGA submissions, clinical trials, and medical device regulation create real compliance exposure. We work closely with you to understand your activities and source a policy that addresses them.

03

Device Design Coverage

Medical device design carries long-tail liability as devices remain in service for years. We access markets that can provide appropriate limits and run-off provisions for this kind of work.

04

Healthcare Integration

Biomedical engineers can be drawn into medical malpractice litigation. We access specialist markets that provide meaningful defence cover for healthcare disputes.

RISK PROFILE

Key Professional Risks for Biomedical Engineers

Biomedical engineering claims often involve patient harm allegations with significant damages. Understanding these exposures is essential for appropriate protection.

Medical device design errors affecting patient safety
Clinical equipment specifications that underperform or malfunction
Prosthetic and implant design failures requiring revision surgery
Biocompatibility advice proving incorrect with patient harm
Regulatory submission errors delaying or preventing device approval
Hospital system integration advice causing treatment delays
Rehabilitation equipment specifications unsuitable for patient needs
Sterilisation and infection control design failures

Your engineering expertise enables medical treatments and patient care. Adequate PI coverage protects your practice when healthcare outcomes are questioned.

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POLICY SCOPE

What Biomedical Engineer PI Insurance Covers

Comprehensive PI insurance for biomedical engineers addresses device design, clinical equipment, regulatory consulting, and healthcare system integration.

Biomedical engineer reviewing designs representing professional indemnity coverage
Biomedical engineer reviewing designs representing professional indemnity coverage

Usually Covered

✓ Medical device design errors affecting patient safety.
✓ Clinical equipment specification failures.
✓ TGA regulatory submission errors and omissions.
✓ Prosthetic and implant design negligence.
✓ Hospital system integration advice failures.
✓ Defence costs for claims and regulatory investigations.

Not Typically Covered

✕ Defective devices you manufacture (Product Liability required).
✕ Clinical treatment you provide as a practitioner.
✕ Deliberate falsification of trial data or fraud.
✕ Bodily injury from site activities (Public Liability required).
✕ Known defects not disclosed when arranging coverage.
✕ Intentional patient harm or criminal conduct.

Biomedical engineering spans device design, clinical systems, and research. Coverage can be arranged for your specific activities and healthcare sector focus.

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QUESTIONS

Frequently Asked Questions

Biomedical engineers commonly seek PI coverage between $5 million and $20 million, given the potential for patient harm claims. Medical device design, clinical equipment consulting, and TGA regulatory work often attract higher limits. We work through your activities and client base to help source coverage that fits.
PI insurance is designed to cover claims alleging your design advice, specifications, or regulatory submissions were negligent and contributed to device failures. Cover typically includes defence costs and damages, though the specifics depend on your policy wording. For devices you manufacture, Product Liability insurance is also worth considering.
PI insurance can cover claims arising from alleged errors in your regulatory submission advice that cause delays, refusals, or post-market issues. If clients allege that errors in your documentation or testing protocols caused regulatory problems, they may look to claim against you. It's worth discussing this exposure with us so we can help source a policy that addresses it.
Clinical trial consulting carries substantial liability exposure. If trial design flaws, protocol errors, or data management issues arise, claims can follow. We arrange coverage that addresses clinical research activities with appropriate limits for this high-risk work.
PI insurance covers claims against you as an engineer providing professional advice. If patient harm occurs from device or equipment failures attributed to your design, you may be joined in medical malpractice litigation. A PI policy is designed to defend and indemnify you in these situations, subject to your policy terms and conditions.

Professional Indemnity Insurance for Biomedical Engineers

Whether you specialise in medical devices, clinical equipment, prosthetics, or healthcare systems, we can arrange PI coverage that addresses the patient safety implications of biomedical consulting.

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