Soapbox

A Single Source of Truth Helps Regulatory Teams

By Laura Jones, ArisGlobal

The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the process, teams generate more robust evidence and stronger submissions, which often means a shorter approval process.

Ethical Considerations for Children in Clinical Investigations:
FDA Publishes New Draft Guidance

By MedTech Intelligence Staff

The guidance seeks to balance the need to obtain data on the safety and effectiveness of drugs, biological products and medical devices in the pediatric population with risks associated with exposure to such products and the reality that children cannot themselves consent to take part in research.

Telemedicine and Healthcare Outside of the Hospital
Connected Care: Digital Health, Wearables & Connectivity

Sponsored By HUMA.AI

Presenters include: Phillip Adamson, MD, Julian Goldman, MD, Mert Aral, MD, Lana Feng, PhD, co-founder of HUMA.AI and Bernhard Kappe, founder of Orthogonal

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AI Applications

By Calum Cunningham, Nuance Communications

Artificial intelligence has numerous practical applications in diagnostic imaging; the key to making them work for clinicians and patients lies in developing and embracing integrated workflow networks.

AHRQ Announces Real World Data Competition for HCOs

By MedTech Intelligence Staff

The competition will explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up to $200,000.

How AI is Powering the Next Generation of Cloud
Quality Management Systems

September 29, 2022 | 12:00 p.m. - 1:00 p.m. ET

Sponsored By ComplianceQuest

As the digital revolution moves us further into the information age, its needs and challenges are becoming clearer. One of the most significant challenges is the growing use of AI in business application suites (i.e., EQMS). In general, AI is leveraged in digital business applications in one or more ways – key to solving process complexity, used in probabilistic predictions or forecasting, minimizing data entry errors, continual improvement and intelligent decision making.

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Featured Quote

Remote care in the home relies both on the quality of patient monitoring and on the insights provided to the care team. There is a real danger that data overload and alert fatigue will undermine otherwise well-designed remote patient monitoring and Hospital at Home programs.

— Jennifer Kent, Parks Associates

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.

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

Siemens PLM for medical devices is an integrated end-to-end product development system that tackles complexity and regulation through re-use, content capture and collaboration.

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

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