Soapbox

Nudging Towards Safer Decision Making

By Laís Junqueira, Elsevier

There is an increased need to foster effective and improved dynamics between people, processes, knowledge and technology to generate an output of safety. “Nudges,” which can help optimize choices by encouraging safer and healthier behaviors, are a promising option.

Bridging the Design Development and Quality Management Chasm

By MedTech Intelligence Staff

Bringing design and quality assurance processes together earlier in the device development process can reduce costs and nonconformances, while improving outcomes.

Getting Your Regulatory Ducks in a Row
Why a Regulatory Information Strategy is Critical
for Successful MDR/IVDR Transitions

Sponsored By Rimsys

James Gianoutsos, CEO and founder of Rimsys, andBruce McKean, director of regulatory at Rimsys, explore the new information requirements associated with MDR/IVDR including GSPRs, UDI/EUDAMED and post-market surveillance and reporting, and discuss how a shift to a product-centric vs. project-centric approach can make information more accessible and usable across teams and processes.

Stream Now!

FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

By MedTech Intelligence Staff

The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.

Veeva Introduces MedTech-Specific Vault CRM

By MedTech Intelligence Staff

Veeva Vault CRM for Medtech is a unified customer relationship management (CRM) and content management application built for medtech sales teams, key account managers and medical affairs professionals.

The Real Impact of IVDR on Clinical Evidence Requirements

By Sean Smith, HUMA.AI

One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.

Featured Quote

Citing studies reaching back to when the pulse oximeter was first introduced in the 1990s, the researchers showcased how the otherwise-accurate technology is limited by the ability of a user to differentiate the warning tones of the device.

— Brian Stallard, AAMI

Predictive Quality for Medical Devices

Sponsored By Critical Manufacturing

Wouldn’t it be great to know and be able to automatically release products when every process stayed within the specified envelope? And to sample or test only as much as a particular process requires, no more or less? Those are the promises of predictive quality. Get to know what executives from Medtronic, B Braun, Jabil and Ultradent have to say about it.

The Impact of Covid-19 on the Medical Device Supply Chain

Sponsored By Loftware

It’s no secret, the medical device supply chain was significantly impacted by the COVID-19 pandemic. Discover how leading medical device manufacturing companies adapted to meet the changing demands with labeling to ensure uptime.

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.

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.

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

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

Sponsored By Innovaccer

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

Sponsored By PTC Arena

Unified Medical Imaging Solutions:
The Next Evolution in Imaging

Sponsored By Arrow and Dell Technologies

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

The Ultimate Guide to Next-Generation Supplier Management

Sponsored By ComplianceQuest