MedTech Intelligence's Connected Care Summit East - March 14-15, 2023 - Washington, DC.

MedTech Intelligence

Volume 15 Issue No. 12



Steven Silverman, The Silverman GroupWhat You Need To Know About FDA
Remote Medical Device Inspections

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.



2023 MedTech Regulatory Performance Report2023 MedTech Regulatory Performance Report

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.

Download to learn more

Featured Articles

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.

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.

Ellsworth Adhesives - Highly Fluorescent Adhesives for high speed inspection


Critical ManufacturingQuality Management and Regulatory Compliance for Medical Devices
- What's in for 2023?

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.

Stream Now!

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.

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.

Devicetalks Boston - May 10-11, 2023

MedTech Library

Industry Survey: Literature Review Automation Adoption Insights and TrendsIndustry Survey:
Literature Review Automation Adoption Insights and Trends

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.

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech ResearchTerumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

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.

AI Medical Device Software Under the MDRAI Medical Device Software Under the MDR

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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May 18-19, 2023

ConnectedCare Summit East

MedTech Intelligence 2023 Washington DC Conferences

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May 16-17
MedTech Regulatory Intelligence Summit

The MedTech Regulatory Intelligence Summit brings together RA/QA professionals, device developers and regulators to share experiences and best practices, and find solutions to the key pain points in achieving regulatory compliance throughout the product lifecycle.
Learn more and register here.

May 18-19
ConnectedCare Summit East

The ConnectedCare Summit East brings together entrepreneurs, innovators, researchers and regulators as we examine what’s next—and what’s holding us back—on the road to a truly connected healthcare system.
Learn more and register here.

November 7-8
MedTech Intelligence Advanced Manufacturing Conference

Join leading MedTech engineers and manufacturers as we take an in-depth look at the use of advanced manufacturing technologies in quality improvement, speeding time to market and combating labor shortages, and share insights on what’s working, implementation challenges and strategies for successful adoption. (Registration opening soon)

November 8-9
MedTech Supply Chain Intelligence Summit

Gain insight and strategies from procurement professionals, device manufacturers and regulators on how to assess and mitigate risks to the supply chain, improve logistics, and build and maintain a sustainable, resilient supply chain. (Registration opening soon)

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