Decentralized Clinical Trials:
Considerations for Implementation

By Myla Maloney and Yosef Khan, Premier PINC AI

Randomized clinical trials are the gold standard for conducting clinical research. They are, however, fraught with issues and come with burdens to the patient, site and sponsor. Decentralized trials (DCTs) allow for a novel, agile and more cost-effective approach to an industry standard and traditional methodology. Here’s how to determine if a full or hybrid DCT is a good option for your clinical trial.

6 Requirements for Medical Device Manufacturers in 2022

Sponsored By Rootstock Cloud ERP

Discover the 6 key requirements to consider when executing your digital transformation strategy and learn how to turn uncertainty and disruption into a model for sustainable growth.

Download to learn more

Next Steps in Wearables

By MedTech Intelligence Staff

John Mastrototaro, Ph.D., biomedical engineer and CEO of Movano discusses strategies to improve data accuracy, the convergence of consumer wearables and medical remote monitoring devices and what healthcare providers are seeking in remote data delivery.

Biocompatibility in MedTech:
Irritation Tests with Skin Models

By Christoph D. Lindner, TÜV SÜD Product Service GmbH

The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.

Checkmate: Post-Market Intelligence
A New Global Cost-Effective Strategy

Understand current post-market surveillance system regulatory requirements and learn more about the benefit of validated AI Systems in the healthcare sector in this complimentary webinar featuring presentations by Dr. Bassil Akra, CEO and owner of Bakra Team GmbH; Joao Martins, PharmD, associate director of regulatory strategy at Abbott-Belgium; Matthias Fink, MD, clinical focus manager-North America at TÜV SÜD America; and Robert Dostert, sales manager at DNV.

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MHRA Responds to Trade Association Concerns
with Transitional Guidance

By MedTech Intelligence Staff

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.

Loftware Recognized as “AIDC Company of the Year”

By MedTech Intelligence Staff

The annual SupplyTech Breakthrough Awards program honors excellence within the supply chain and logistics sectors.

Featured Quote

Cybersecurity in the healthcare sector is too critical to leave to anything less than a robust approach. The industry is too great a target for cyberattacks from opportunistic criminals.

— Scott Trevino, TRIMEDIX

Adapting to COVID-19 with simulation in the medical device industry

Sponsored By Siemens

Learn how medical device manufacturers are using simulation to enhance their design process to help fight COVID-19 and continuously innovate.

Preparing for Europe’s New Medical Device Regulation:
The Essential Guide to EU MDR Compliance

Sponsored By PTC Arena

Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

Launching your medical device:
A strategy & execution cross-functional guide

Sponsored By Definitive Healthcare

Learn how the experts launch their medical devices. Definitive Healthcare’s eBook cowritten by Carl Zeiss Meditec Inc. is packed with checklists and descriptions of all major pre-launch action items each team in your org needs to complete to successfully launch your device.

Data Curation: Enabling your Digital Strategy with a Comprehensive Data Strategy

Sponsored By Innovaccer

Through this whitepaper look under the hood to see how Innovaccer can help life-science companies address these challenges and move towards the digital disease management ecosystem.

7 Principles of Product-Centric Quality Management:
A Guide for Medical Device Innovators

Sponsored By PTC Arena

Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

Unified Medical Imaging Solutions:
The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

Effective data management and processing challenges need to be addressed seamlessly for modern imaging solutions to facilitate quick and precise diagnosis, augment business workflow, and improve patient care.

The Rise of Implantable Devices

Sponsored By AMETEK-COINING

Medical device design control with Siemens Digital Industries Software

Sponsored By Siemens

The Post-Market Gambit: After EU MDR and IVDR:
A Systematic Compliance Framework for Driving MedTech Innovation

Sponsored By Huma.AI

How to Address the Top Four Labeling Challenges Facing Medical Device Manufacturers

Sponsored By Loftware, Inc.

The Ultimate Guide to Next-Generation Supplier Management

Sponsored By ComplianceQuest