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.

Why a Product-Centric Approach to Quality Matters

October 6, 2022 | 12:00 p.m. - 1:00 p.m. ET

Sponsored By Arena, a PTC Business

Hear from a panel of industry experts with in-depth experience bringing FDA-regulated products to market and know what’s needed to meet product development, quality, and compliance goals despite today’s obstacles.

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White Houses Releases AI Bill of Rights Blueprint

By MedTech Intelligence Staff

On Tuesday, October 4, the White House released a Blueprint for an Artificial Intelligence (AI) Bill of Rights geared toward protecting the American public as the use of AI and machine learning expands throughout industry and online.

Raising the Bar on Quality for MedTech Production

By Mohamed Benkirane, Critical Manufacturing

Inspecting for quality after a process is completed is reactive and outdated. Instead, the future lies in predicting quality and quality issues. For medical device manufacturers, the advantages in predictive quality are so great they simply cannot be ignored.

M&As: Maximizing the Partnership Process on Both Sides

By Leslie Storms, Ethicon, Martha Shadan, Miach Orthopaedics, and Kristine Iliara, Smith+Nephew

Leslie Storms, U.S. president of Ethicon, Martha Shadan, CEO of Miach Orthopedics, and Kristine Ilaria, vice president of Corporate Development at Smith+Nephew, share lessons learned from their panel “Making Acquisition Strategy Succeed: Perspectives from Both Sides of The Deal.”

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

Sponsored By ComplianceQuest

Sundeep Agarwal, trainer and consultant in the fields of Quality Assurance, Regulatory Affairs, Artificial Intelligence, Risk Management and Industrial Manufacturing, discusses how AI and hyperautomation work to eliminate redundant procedures, provide and classify in-depth analytics and enhance efficiency and traceability.

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Taylor Named Chief Technology Officer of ETQ

By MedTech Intelligence Staff

John Taylor has 30 years of software development and senior leadership experience. Prior to joining ETQ in 2018, he was senior vice president with PTC.

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.

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Featured Quote

As supply chain issues continue to cause delays in production and the threat of natural disasters continues to grow, it has never been more important for medical technology manufacturers to prepare for whatever business interruptions might come their way.

— Steve Severaid, Greenspan Co./Adjusters International

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

The Ultimate Guide to Next-Generation Supplier Management

Sponsored By ComplianceQuest