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Blogg: 2023-09-11

Can I ask ChatGPT to write my medtech product's regulatory documents?

One of our customers asked us, can we ask ChatGPT to write our Clinical Evaluation Plan? So, we did a little experiment and tried to do this. Here are some results from our experiment.

  • A generic CEP with no device-specific detail. You’ll have to provide it. So, that is no CEP at all.
  • It does not know how a regulatory authority will interpret a requirement.
  • ChatGPT throws out specific answers to very specific questions. So, it needs to be given incredibly specific instructions. Unless, you know the specific questions regulatory authorities will get into, you can’t get the right answers from ChatGPT.

And, as you may have noticed - If you type anything related to regulatory/legal matters eg: the MDR or the GDPR, ChatGPT always asks you to consult an expert. So, if you do decide to go by what ChatGPT says, you can talk to our experts at Prevas.The next common question we get from customers is about templates. So many e-QMS providers are selling this out there.

Hållbara vardagshjältar behövs

Should I hire a consultant to write an SOP from scratch? (or) Should we buy pre-made template packages?The answer is it is hard to tell. Here are some reasons:

  • Template quality: We need to consider the quality of the template. Sometimes, calling on consultants to fix a bad template may take more time than building one from scratch.
  • In-depth analysis of compliance is needed: Our clients often assume that the template is ready-to-use. Unfortunately, this is not the case. An expert is required to look at the nitty-gritty.

Here is where experts are involved with a pre-made template.

  • Compliance: Check compliance with device-specific regulatory requirements and standards. This is often lacking in a pre-made template.

Check if it has the right level. If it's a class I device, you may be exempt from some regulatory requirements stated in the generalized template.

  • Add device-specific info: Regulations applicable to the specific in these pre-made templates.
  • Ensuring 'connections' to other processes: There needs to be a ‘red thread’ connecting all your processes. Any plans you write must communicate with your other processes. There needs to be a link. Eg: clinical evaluation must be linked to risk management.
  • Clarifications: Someone else wrote the pre-made templates. Therefore, it is sometimes hard to explain what is exactly meant. While this is true for clinical evaluation. It is also true for all your other processes.

Moral of the story: Templates don’t necessarily save time. Starting an SOP from scratch doesn’t necessarily add time.Establishing the right level for each device is important. Our quality experts have spent decade understanding this.

If you have questions about going for an QMS (e-QMS Vs a paper-based) QMS adding on a process, or preparing technical documentation, feel free to contact us for a free consultation.

Get in touch with:
Sara Löfberg, e-post
Anna-Karin Alm, e-post


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