Sartorius - Manufacturing & Quality Control for Medical Devices

MedTech Intelligence

Volume 15 Issue No. 13


Sarah Carpenter, AssentMedical Technology and ESG:
Solving the Data Problem

By Sarah Carpenter, Assent

Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.



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.

Download to learn more

Featured Articles

Remote Monitoring Technology Improves Survival in
Heart Failure Patients

By MedTech Intelligence Staff

New data presented at the Technology and Heart Failure Therapeutics (THT) Conference showed that hemodynamic monitoring can slow the progression of heart failure in patients with reduced ejection fraction.

FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices

By MedTech Intelligence Staff

The final guidance includes recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including selecting an appropriate animal model, study monitoring, and study evaluation.

Rimsys - 2023 MedTech Regulatory Performance Report


Transforming Medical Device Sales
for the Digital World

Sponsored By Experlogix

Medical and mobility device manufacturers face complex pricing scenarios, stringent industry regulations and ever-changing product variations in a highly competitive market. In this webinar, Charles Sapienza, senior sales director of Experlogix, explores how CPQ and Document Automation software can help manufacturers overcome these challenges, provide more visibility into sales performance and sell more efficiently.

Stream Now!

Protecting Innovation in FemTech

By Meggan Duffy and Julianne Hartzell, Marshall, Gerstein & Borun LLP

How innovators in the femtech space can protect their inventions and defend market share.

Qiagen CEO Named Chair of AdvaMedDx Board of Directors

By MedTech Intelligence Staff

“I am honored to welcome Thierry Bernard as the new chair of the AdvaMedDx Board. With his decades of experience, Thierry brings a clear vision of the work we can accomplish, and I look forward to working with him.”

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.

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.

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.

All Available Resources

MedTech Regulatory Intelligence Summit, May 16-17, 2023, Washington, DC

Upcoming Events & Webinars

May 18-19, 2023

ConnectedCare Summit East

MedTech Intelligence 2023 Washington DC Conferences

More info at

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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