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Volume 15 Issue No. 12 |
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Soapbox
By Steven Silverman, The Silverman Group The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model. |
What You Need To Know About FDA|
SPONSORED RESOURCE |
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Sponsored By Rimsys The 2023 MedTech Regulatory Performance Report provides insights and process benchmarks from a survey of 200 medtech regulatory professionals across North America and Europe. The report explores regulatory staffing and team size, workload and average times to complete regulatory projects, compliance issues and costs, and the role of technology and digital transformation. |
2023 MedTech Regulatory Performance Report| Featured Articles |
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How a Comprehensive UX Approach Brings Value to the Design Process By Philip Remedios and Irina Samkova, BlackHägen Design UX (user experience) design processes are constantly evolving as the industry continues to embrace IoT technologies. With this evolution comes a need to focus on improving UX protocols in the design of medical devices. |
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From The Editor's Desk Expand Your Regulatory Intelligence By MedTech Intelligence Staff On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements. |
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COMPLIMENTARY ON DEMAND WEBINAR |
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Sponsored By Critical Manufacturing How do you make the regulatory burdens work to your organization’s benefit? Stefan Koch of Frontwell Solutions, and Jeff Richardson and Rogério Ferreira of Critical Manufacturing discuss how companies are maintaining compliance, automating validation using reasonable, efficient, and modern methodologies, and what an MES will mean for quality, costs, and risk in 2023. |
Quality Management and Regulatory Compliance for Medical Devices|
Clock Starts for New EU MDR Transition Dates By MedTech Intelligence Staff On Monday, March 20, the EU MDR Extension Approved on March 7 came into effect following its official publication in the Journal of the European Union. |
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MedTech Developers Can Improve Surgical Workflows Through Thoughtful Innovation By Tommy Carls, Proprio As surgeries become increasingly complex and involve more sophisticated technology, the mental and physical demands on surgeons and their teams are expected to increase. As an industry, we need to thoughtfully consider how each piece of technology introduced into operating rooms will impact existing surgical workflow and workloads. |
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| MedTech Library | |
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Sponsored By DistillerSR DistillerSR, in partnership with Citeline, surveyed global professionals in the medical device and in-vitro diagnostics industry to understand organizational preparedness and management maturity towards literature review practices. |
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Sponsored By Veeva Medtech Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business. |
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Sponsored By DNV This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market. |
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| Upcoming Events & Webinars |
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March 29, 2023 - 1:00 pm – 2:00 pm |
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May 16-17, 2023 |
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May 18-19, 2023 |
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MedTech Intelligence 2023 Washington DC Conferences More info at MedTechIntelligence.com May 16-17 May 18-19 November 7-8 November 8-9 |
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