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Agenda
Clinical 2.0 Track
Comparing and Contrasting Global Regulatory Requirements for Clinical Evaluation Reports (CERs). Highlighting: Japan, China, Europe, Australia and ASAEN
Health Economics Analyses and its Role in Medical Device Adoption
Avoiding Pitfalls and Mitigating Risk Throughout a Clinical Trial
U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success
Technology Track
The State of R&D at the big companies
3D Printing: A Primer
Neuromodulation
Cybersecurity and MedTech
The Science of Skin: Designing Wearable Medical Devices
AI in MedTech
Ecosystem Track
The Changing Face of MedTech: Attracting and Keeping an Inclusive Workforce
Strategies for Today’s Funding Landscape
Getting to the Exit
Meet Your Local MedTech Reporters
From Mind to Matter: Addressing the Opioid Crisis Through a Hands-On User-Centered Innovation Process
Provider Perspectives: What Do Our Customers Want?
Regulatory 2.0
FDA Strategic Initiatives
Digital Health and Software as a Medical Device (SaMD)
Real World Evidence / Patient Preference Initiative
Novel Pathways to FDA and CMS Approval: Parallel Review in Medical Devices
Transitioning from MDD to MDR: How is this REALLY rolling out? Tips, Tricks, and Lessons Learned from Large Program Implementation
Portfolio Planning as an input to your EU MDR implementation plan. Which devices should stay and which should go? Balancing the cost and effort of transitioning to the EU MDR with product life cycle planning and revenue expectations
Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant Clinical Evaluation Reports (CERs): What We’ve Learned From Completing 100+
Post market surveillance under EU MDR – do I have to run a clinical study? What other options do you have to fulfill post market surveillance requirements; including updating CERs
Keynotes
Keynote: Heidi Dohse
Dinner & Keynote: Michael J. Pederson, Abbott
Keynote: Inside Bigfoot Biomedical
Closing Keynote
Events
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2017
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Home
Agenda
Clinical 2.0 Track
Comparing and Contrasting Global Regulatory Requirements for Clinical Evaluation Reports (CERs). Highlighting: Japan, China, Europe, Australia and ASAEN
Health Economics Analyses and its Role in Medical Device Adoption
Avoiding Pitfalls and Mitigating Risk Throughout a Clinical Trial
U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success
Technology Track
The State of R&D at the big companies
3D Printing: A Primer
Neuromodulation
Cybersecurity and MedTech
The Science of Skin: Designing Wearable Medical Devices
AI in MedTech
Ecosystem Track
The Changing Face of MedTech: Attracting and Keeping an Inclusive Workforce
Strategies for Today’s Funding Landscape
Getting to the Exit
Meet Your Local MedTech Reporters
From Mind to Matter: Addressing the Opioid Crisis Through a Hands-On User-Centered Innovation Process
Provider Perspectives: What Do Our Customers Want?
Regulatory 2.0
FDA Strategic Initiatives
Digital Health and Software as a Medical Device (SaMD)
Real World Evidence / Patient Preference Initiative
Novel Pathways to FDA and CMS Approval: Parallel Review in Medical Devices
Transitioning from MDD to MDR: How is this REALLY rolling out? Tips, Tricks, and Lessons Learned from Large Program Implementation
Portfolio Planning as an input to your EU MDR implementation plan. Which devices should stay and which should go? Balancing the cost and effort of transitioning to the EU MDR with product life cycle planning and revenue expectations
Achieving MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant Clinical Evaluation Reports (CERs): What We’ve Learned From Completing 100+
Post market surveillance under EU MDR – do I have to run a clinical study? What other options do you have to fulfill post market surveillance requirements; including updating CERs
Keynotes
Keynote: Heidi Dohse
Dinner & Keynote: Michael J. Pederson, Abbott
Keynote: Inside Bigfoot Biomedical
Closing Keynote
Events
Home
Boston
West
Minnesota
2017
Photos
2016
Photos
2015
Photos
2014
Photos
Exhibitors
Exhibit Sponsorship
Travel
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Karen Nordahl
Director of Health Economics and Market Access, Boston Scientific
Karen Nordahl
Director of Health Economics and Market Access, Boston Scientific
Biography
Conference Track: Novel Pathways to FDA and CMS Approval: Parallel Review in Medical Devices
