There are a number of different perspectives on this, some diametrically opposed. When it comes to professional liability, I tend to go with risk management over risk avoidance:
- Sign nothing on behalf of a client.
- Include language in your contract similar to what the software industry used to put on its software, which basically said that it doesn't warrant that its software is good for anything. (Seriously, that used to be a sticker on the back of each disk, when software was distributed on disks. It's probably buried somewhere in the cloud now, but I would guess it's still there somewhere.) No one ever knows what regulators will do, and your client should take full responsibility for everything. It's their product, after all, not yours.
- Keep your pockets shallow. I agree with those who think that insurance mostly makes you a target for litigation, because that means there is a nice pot of money there to be sued for.
To me, the only reason for a consultant to have professional liability insurance is as evidence that you really are a professional consultant, not someone who is unemployed and doesn't want to say so, or a contract laborer and nobody wants to say so.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Jul-2017 14:02
From: Maria Laitenberger
Subject: Professional Liability Insurance - Any suggestion?
I'm a biomedical engineer, now working full time in Regulatory Affairs and Quality Assurance as a consultant for the medical device industry, and also a RAPS member. I used to work in Canada but I am now located in New Zealand. My current clients are located in the USA, but they could potentially be from anywhere.
My professional liability insurance contract with a Canadian insurance company is about to expire and I am looking into my options. I saw that RAPS offers a discounted professional liability insurance through Vaughan Insurance Group:
But unfortunately they told me that they don't have a specific program for individuals domiciled outside the US.
I would like to know if you are aware of any other companies which serve Regulatory Affairs professionals but with international coverage?
The previous one that I had was exclusively for engineers and therefore they had a hard time finding something that really fits my professional activities. I feel like I paid too much for the actual risk related to my work. I would like to find a company that better understands the nature of work related to Regulatory Affairs/Quality Assurance in the medical device industry and that is flexible enough to cover me internationally.
Thanks in advance!
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Maria Laitenberger, Jr. Eng., M.A.Sc., RAC
Regulatory Affairs and Quality Assurance Consultant
New Zealand
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