BIVDA Regulatory Affairs Seminar 2022

Regulatory Affairs Working Party Seminar 2022 Feedback Survey

Thank you for attending our Regulatory Affairs Seminar. We hope that you found the seminar informative and worthwhile.

To assist us in improving our service to you would it be possible for you to complete the survey below.

Question Title

* 1. Please give your assessment of the standard and content of the presentations at BIVDA's Regulatory Affairs Seminar 2022:

	Poor 1	2	3	4	Excellent 5
Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix	Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix Poor 1	Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix 2	Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix 3	Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix 4	Day 1 Session 1 - Industry spotlight: How is an SME managing the changing regulatory landscape? James Shearn, RegCentrix Excellent 5
Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis	Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis Poor 1	Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis 2	Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis 3	Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis 4	Day 1 Session 2 - Swiss Regulations: Overview of the Swiss Regulatory structure and the key differences from IVDR Emilia Berg, Confinis Excellent 5
Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe	Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe Poor 1	Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe 2	Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe 3	Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe 4	Day 1 Session 3 - Sustainability: The impact on IVDs Valerie Rampi, MedTech Europe Excellent 5
Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve	Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve Poor 1	Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve 2	Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve 3	Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve 4	Day 1 Session 4 - The role of software and AI in IVDs Tim Davison, Qserve Excellent 5
Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA	Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA Poor 1	Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA 2	Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA 3	Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA 4	Day 1 Session 5 - UKCA Regulations: MHRA perspective and what is still to come Penny Wilson, MHRA Excellent 5
Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA	Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA Poor 1	Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA 2	Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA 3	Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA 4	Day 1 Session 6 - UKCA Regulations: Industry perspective and what is still needed Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA Excellent 5
Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology	Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology Poor 1	Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology 2	Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology 3	Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology 4	Day 1 Session 7 - UKCA panel session Penny Wilson, MHRA; Mike Messenger, FIND & ACT-IVD; Camilla Fleetcroft, ECLEVAR; Ashleigh Batchen, BIVDA; Stuart Angell, IVDeology Excellent 5
Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics	Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics Poor 1	Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 2	Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 3	Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 4	Day 2 Session 1 - Update from MedTech Europe Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics Excellent 5
Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS	Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS Poor 1	Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS 2	Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS 3	Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS 4	Day 2 Session 2 – UKAS update on ISO 15189 Alyson Bryant, UKAS Excellent 5
Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics	Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics Poor 1	Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 2	Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 3	Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics 4	Day 2 Session 3 – IVDR: Significant changes Petra Zoellner, MedTech Europe; Andrew Rutter, EKF Diagnostics Excellent 5
Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA	Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA Poor 1	Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA 2	Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA 3	Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA 4	Day 2 Session 4 – Workshop: What is the reality of determining if a change is significant? Petra Zoellner, MedTech Europe; Stuart Angell, IVDeology; Richard Saunders, Ortho Clinical Diagnostics; Andrew Rutter, EKF Diagnostics; Ashleigh Batchen, BIVDA Excellent 5
Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics	Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics Poor 1	Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics 2	Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics 3	Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics 4	Day 2 Session 5 - Industry spotlight: How is a multi-national organisation managing the changing regulatory landscape? Simon Richards, Abbott; Richard Saunders, Ortho Clinical Diagnostics Excellent 5
Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics	Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics Poor 1	Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics 2	Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics 3	Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics 4	Day 2 Session 6 - Notified Body and Approved Body panel session Suzanne Halliday, BSI; Craig Milner, DEKRA; Andreas Strange, TUV SUD; Andrew Rutter, EKF Diagnostics Excellent 5

Any comments about the presentations

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* 2. How did you feel about the length of the seminar?

Too short

Too long

About right

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* 3. Were the presentations detailed enough?

Too little

Too much

About right

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* 4. Did you find the seminar relevant to your needs?

Very relevant

Not at all relevant

About right

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* 5. Any other comments about the content?

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* 6. Are there any other topics you would like to have covered or dealt with more fully?

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* 7. Please give us your assessment of whether the presentations were useful and of the way they were presented.

	Poor 1	2	3	4	Excellent 5
Usefulness	Usefulness Poor 1	Usefulness 2	Usefulness 3	Usefulness 4	Usefulness Excellent 5
Presentation	Presentation Poor 1	Presentation 2	Presentation 3	Presentation 4	Presentation Excellent 5

Any comments about the documents

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* 8. What was your experience in using the BIVDA Mobile app?

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* 9. Was the seminar efficiently organised?

	Poor 1	2	3	4	Excellent 5
Invitations and information beforehand	Invitations and information beforehand Poor 1	Invitations and information beforehand 2	Invitations and information beforehand 3	Invitations and information beforehand 4	Invitations and information beforehand Excellent 5
On the day	On the day Poor 1	On the day 2	On the day 3	On the day 4	On the day Excellent 5
Breakout sessions	Breakout sessions Poor 1	Breakout sessions 2	Breakout sessions 3	Breakout sessions 4	Breakout sessions Excellent 5

Any comments on the organisation

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* 10. Was the dinner venue/entertainment efficiently organised?

	Poor 1	2	3	4	Excellent 5
Venue	Venue Poor 1	Venue 2	Venue 3	Venue 4	Venue Excellent 5
Entertainment	Entertainment Poor 1	Entertainment 2	Entertainment 3	Entertainment 4	Entertainment Excellent 5

BIVDA Regulatory Affairs Seminar 2022

Regulatory Affairs Working Party Seminar 2022 Feedback Survey

Question Title

* 1. Please give your assessment of the standard and content of the presentations at BIVDA's Regulatory Affairs Seminar 2022:

Question Title

* 2. How did you feel about the length of the seminar?

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* 3. Were the presentations detailed enough?

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* 4. Did you find the seminar relevant to your needs?

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* 5. Any other comments about the content?

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* 6. Are there any other topics you would like to have covered or dealt with more fully?

Question Title

* 7. Please give us your assessment of whether the presentations were useful and of the way they were presented.

Question Title

* 8. What was your experience in using the BIVDA Mobile app?

Question Title

* 9. Was the seminar efficiently organised?

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* 10. Was the dinner venue/entertainment efficiently organised?

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* 11. Can you suggest a location for next year's seminar?

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* 12. Would you prefer the seminar to be held twice a year?

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* 13. What if anything did you dislike about the seminar?

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* 14. Your details