Free Seminar – Incident Reporting/PMS – 19 June – Kista

Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market.

Information
After years of development and testing, bringing your medical device to market is an exciting achievement. 

However, your work isn’t finished yet. Once your product is in the hands of the public, you must ensure it continues to meet the needs of patients and healthcare providers. This is where post-market surveillance (PMS) comes into play.

Speaker
QAdvis newest consultant with previous experience from Läkemedelsverket, Marie Mathiasson.

Date/Time
19 June, 14.30 – 15.30 including Q&A

Welcome to a pre-chat with coffee and cake (get some Swedish fika) from 13.30, meet our speaker and mingle with other industry colleagues. 

Location: QAdvis Office, 33 Färögatan, 164 51 Kista
The main reception is located in Kista Science Tower. More detailed information will be sent to you the day before the event.

Register at Eventbrite

Note: The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. (If you register but don’t attend, you will be charged 200 SEK.)

If you have any question, contact us at info@qadvis.com.

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Free Seminar – Incident Reporting/PMS – 13 June – Lund

Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market.

Information
After years of development and testing, bringing your medical device to market is an exciting achievement. 

However, your work isn’t finished yet. Once your product is in the hands of the public, you must ensure it continues to meet the needs of patients and healthcare providers. This is where post-market surveillance (PMS) comes into play.

Speaker
QAdvis newest consultant with previous experience from Läkemedelsverket, Marie Mathiasson.

Date/Time
13 June, 14.00 – 15.00 including Q&A

Welcome to a pre-chat with coffee and cake (get some Swedish fika) from 13.30, meet our speaker and mingle with other industry colleagues. 

Location: Medicon Village
The main reception is located in The Spark at Scheeletorget 1 in Lund. More detailed information will be sent to you the day before the event.

Register at Eventbrite

Note: The event is free but space is limited. If you are not able to participate, we urge you to make a cancelation as soon as possible or assign your place to a colleague. (If you register but don’t attend, you will be charged 200 SEK.)

If you have any question, contact us at info@qadvis.com.

Follow us on LinkedIn!

Will AI replace your doctor?

AI enabled medical devices are increasingly making their way into every sector of the medical profession, supporting decision-making that could potentially affect life or death for patients. As these technologies improve, a pressing question emerges: Should we trust AI or the doctor?

AI enabled medical devices are becoming more prevalent and powerful, raising new challenges and ethical questions regarding human oversight and responsibility. We accept human mistakes as inevitable, yet we hold AI to higher standards. According to the WHO ethical principles, AI should not replace human decision-making, but rather augment it, and humans should always have the final say on health matters. But when AI outperforms doctors, which should we trust more?

Device manufacturers currently try to avoid liability issues by stating for example, that the AI does not make a diagnosis, it is only a suggestion etc., but we all know that we humans tend to take the least burdensome approach, especially under stressful conditions. This could especially be a risk with younger, less experienced medical staff. If the AI was correct in 99 cases out of a hundred, why wouldn´t it be right on the hundredth too? Studies suggest that AI could indeed reduce misdiagnosis rates, especially for rare diseases, where only the most skilled doctors can match the ability of AI.

Interestingly, some AI systems can now monitor a doctor’s surgical performance and suggest technique improvements during operations. This raises the question: Who is monitoring whom?

There are numerous questions to address to ensure that AI-enabled medical devices can maximise their potential benefits while minimizing their potential risks. With a clear and consistent framework for assessing and regulating AI-enabled medical devices, we can put our trust in them – or rather in the people that made them.

Will AI then replace doctors? Well, there’s a famous saying – Its origin unclear – that AI is not going to replace your doctor, but the doctor using AI will replace the one who doesn’t.

If you have any question, contact us at info@qadvis.com.

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