Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
Europe
+33 (0)1 42 68 51 79
Japan
+81 (0)3 6260 6688
United States
+1 972 480 9554
Over the past 15 years, Ken Block Consulting (KBC) has been invited by medical device industry groups, quality and regulatory associations, educational conference organizers and startup accelerators to author and present speeches at events across the globe. Our hosts have included Regulatory Affairs Professionals Society (RAPS) Japan, American Society for Quality (ASQ), American Medical Devices and Diagnostic Manufacturer's Association (AMDD), Japanese Imaging and Radiological Association (JIRA), and many others including medical device trade shows in the UK, Japan, Ireland, France, Germany, etc. To date, we have given over 50 such speeches, each containing unique content focused on the industry professionals attending these international events, from executives and engineers to regulatory and quality professionals. The broad range of speech topics matches the deep KBC hands-on experience in these areas including cybersecurity, 3D device printing, investigational device studies, newly released FDA guidance documents, software validation, FDA inspections, market entry strategy, and more.
Anticipated New FDA Quality Management System Regulation (QMSR) Final Rule, Japan Association of Clinical Reagents Industries (JACRI), November 28, 2023 [Tokyo, Japan]
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Recent FDA 510(k)-Related Guidance Documents, Japan Association of Clinical Reagents Industries (JACRI), November 28, 2023 [Tokyo, Japan]
Racial and Ethnical Diversity in Medical Device Clinical Research: FDA Expectations and Feedback, Society for Clinical Research Associates (SOCRA) Annual Conference, 2021 [Online]
FDA Cybersecurity Expectations and Lessons Learned, Medical Technology UK, March 2022 [Coventry, UK]
M&A Due Diligence, Med-Tech Innovation, 2021 [Birmingham, UK]
FDA Design Control Requirements for Medical Device Research, Society for Clinical Research Associates (SOCRA) Annual Conference, 2021 [Online]
Market Access Japan Case Study: Entering the Medtech Market in Japan, Medtec LIVE Exhibition Forum (International Market Access), 2019 [Nürnberg, Germany]
Market Access US: Rapidly Changing US FDA Regulations, Medtec LIVE Exhibition Forum (International Market Access), 2019 [Nürnberg, Germany]
Current FDA Expectations for 3D Printed Devices, American Society for Quality (ASQ) World Conference on Quality and Improvement, 2019 [Ft. Worth, Texas]
FDA regulation change: latest information and future movements, MEDTEC Japan, 2019 [Tokyo, Japan]
Impact of Artificial Intelligence (AI) on the Regulated Medical Device Company, Medical Technology Ireland, 2018 [Galway, Ireland]
3D Printing: FDA and EU Expectations, Medical Technology Ireland, 2018 [Galway, Ireland]
CLIA ’88 Fundamentals for Manufacturers, Japanese Association of Clinical Reagents Industries (JACRI), 2018 [Tokyo, Japan]
Meeting the Newest FDA Expectations for Innovative Software, Med-Tech Innovation (HealthTech Stage), 2018 [Coventry, UK]
Costs of Nonconformity, MEDTEC Japan, 2018 [Tokyo Japan]
Clinical Evaluation Guidance, Medtec Europe (Smart Manufacturing Forum: Regulatory Update), 2018 [Stuttgart, Germany]
Regulatory Considerations for Combination Products, Medtec Europe (Startup & Innovation Forum: Med Tech Meets Pharma), 2018 [Stuttgart, Germany]
Current FDA Expectations for 3D Printed Devices, MEDTEC Europe (Smart Manufacturing Forum: 3D Printing), 2018 [Stuttgart, Germany]
Software Validation of Medtech Apps & Wearables, The National Medtech & Biotech Summit, 2018 [Dublin, Ireland]
Regulatory Workshop for Startups, MEDTEC Ireland, 2017 [Galway, Ireland]
U.S. Market Focus: FDA Hot Topics, Medical Technology Ireland, 2017 [Galway, Ireland]
Regulations for Exporting Medical Devices to the United States Overview, Fukushima Innovation Beyond 3.11, 2017 [Fukushima, Japan]
FDA Unique Device Identifier (UDI) Regulation, Fukushima Innovation Beyond 3.11, 2016 [Fukushima, Japan]
Regulatory Considerations for Medical Device Software, MEDTEC Ireland, 2015 [Galway, Ireland]
Developing a strategic medical device clearance and approval plan and meeting performance and usability testing requirements for device approval, MEDTEC Europe, 2015 [Stuttgart, Germany]
Access to the European and American markets: a look at the European development and outlook for these markets, MEDTEC France, 2014 [Lyon, France]
Examining recent initiatives and legislative changes of the US FDA to hasten the access of medical device technology and shorten the time to market, MEDTEC Europe, 2014 [Stuttgart, Germany]
Overcoming the key challenges presented by FDA and meeting regulatory expectations: FDA Perspective, MEDTEC Europe, 2014 [Stuttgart, Germany]
FDA Regulations & Entrepreneurship, IEEE Medical Device Symposium (Medical Device Innovation in 21st Century), 2013 [Richardson, Texas]
Global Regulation Roundup: U.S. Market Perspective, Wireless Connectivity in Medical Devices, 2013 [Munich, Germany]
FDA Changes and effects on exports to U.S., MEDTEC France, 2013 [Lyon, France]
FDA Software Update: Mobile Health / Mobile Apps, MEDTEC France, 2013 [Lyon, France]
Updates on the U.S. Approval & Regulatory Systems, MEDTEC Europe (U.S. Regulations & Market Access), 2013 [Stuttgart, Germany]
Regulations and Guidance for Mobile Medical Apps, MEDTEC Europe (Wireless Connectivity), 2013 [Stuttgart, Germany]
FDA Software Update: Mobile Health / Mobile Apps, MEDTEC Europe, 2013 [Stuttgart, Germany]
FDA “Hot Topics” (New Laws & Rules: Contents & Implications), NTEC, 2012 [Frisco, Texas]
FDA update: Topics requested by JACRI, Japanese Association of Clinical Reagents Industries (JACRI), 2012 [Tokyo, Japan]
FDA Software Update: Software Related Issues, Japanese Industries Association of Radiological Systems (JIRA), 2012 [Tokyo, Japan]
FDA regulation for mobile health and its future possibilities, Medical Device Development/Manufacturing Exhibition (MEDIX), 2012 [Tokyo, Japan]
FDA Regulatory Update, NTEC (Mobile Health Series), 2012 [Frisco, Texas]
What is necessary in order to provide medical devices in the US market, MEDTEC Japan, 2012 [Tokyo Japan]
FDA Developments and Implications for Medical Device Manufacturers, Texas Instruments (Medical Electronic Technology Seminar), 2012 [Vancouver, Canada]
FDA Software Compliance: Application Software Issues, Japanese Industries Association of Radiological Systems (JIRA), 2011 [Tokyo, Japan]
FDA Software Compliance: ASP Data Center, Japanese Industries Association of Radiological Systems (JIRA), 2011 [Tokyo, Japan]
510(k) medical device regulations: FDA trends, MEDTEC Japan, 2011 [Tokyo, Japan]
FDA Updates, Japanese Association of Clinical Reagents Industries (JACRI), 2010 [Tokyo, Japan]
Risk management requirements and review of FDA CDRH pre-marketing application [510 (k), PMA], Regulatory Affairs Professionals Society (RAPS), 2010 [Tokyo, Japan]
FDA Software Regulations and 510(k) System Update, Japanese Industries Association of Radiological Systems (JIRA), 2010 [Tokyo, Japan]
FDA Update Regarding 510(k) System, American Medical Devices and Diagnostic Manufacturers’ Association (AMDD), 2010 [Tokyo, Japan]
FDA Regulations in Medical Device Software, American Medical Devices and Diagnostic Manufacturers’ Association (AMDD), 2010 [Tokyo, Japan]
FDA Regulations of Medical Imaging Software, Japanese Industries Association of Radiological Systems (JIRA), 2009 [Tokyo, Japan]
FDA policy and 510(k) review changes by new top management, Japanese Association of Clinical Reagents Industries (JACRI), 2009 [Tokyo, Japan]
US FDA China Office Purpose and What's New, Japanese Association of Clinical Reagents Industries (JACRI), 2009 [Tokyo, Japan]
Gathering Investigational Device Data in the United States, Japanese Industries Association of Radiological Systems (JIRA) including attendees from Japanese Electronics and Information Technology Association (JEITA), 2009 [Tokyo, Japan]