State-of-the-Art:
Unpacking MDR’s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.

Swiss National Council Votes To Accept FDA Approved Medical Devices

By MedTech Intelligence Staff

In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles.

How Can AI Make Medical Device Manufacturing Better?

By MedTech Intelligence Staff

How can AI become a beneficial medical device manufacturing technology? This article reviews some examples of how it excels.

Ask the Expert:
EU MDR as a Trigger for Innovation

EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.

Three Things You Need to Know About FDA QSR and
ISO 13485 Harmonization

By Etienne Nichols, Greenlight Guru

New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.

The Evolution of Medical Device Cybersecurity Threats
in the Wake of COVID-19

By Doug Folsom, Trimedx

The omicron variant of the coronavirus has made clear that the impact of the pandemic is far from over, particularly for health systems and hospitals. The ongoing need to limit close contact between providers and patients means technology will continue to play a key role, but with that increased reliance on technology comes the heightened exposure to cyber risks, as well.

Evolving the Field of Neuromodulation:
Four Trends Driving the Shift to Personalized Care

By Dave Anderson, Medtronic

There is significant opportunity to develop therapies that create new standards of care and initiate a new wave of precision medicine.

The Future Is Now:
Digital Technologies that Are Revolutionizing the Medical Device Industry

By Bob Tilling, Kallik

2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.

Artificial Intelligence Boosts New Era of Postmarket Intelligence

By Maria Fontanazza

Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.

Why the Future of U.S. Patient Care Begins with Interoperability

By Joerg Schwarz, Ph.D., Infor

The combination of medtech progress with strides in modern healthcare interoperability will enable preventive care in unprecedented ways.

The Same, But Not Identical:
Demonstrating Biological Equivalence Under MDR

By Jaishankar Kutty, Ph.D., RQM+

Gain insight into the notified body approach to assessing biological equivalence and how manufacturers can make sure their equivalence justifications pass notified body review.

AI 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.

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box
to Streamline, Enhance Quality

Sponsored By etq, part of Hexagon

Symmetry Surgical^® is a leading healthcare technology and solutions provider of high-quality surgical instrumentation, a full-line electrosurgery portfolio, and minimally invasive surgical devices. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.

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

Sponsored By Huma.AI

Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision for a New Era of Post-Market Intelligence.

Increase agility and innovation with PLM for medical devices

Sponsored By Siemens

With medical devices becoming more complex and regulatory oversight becoming stricter, it is difficult for manufacturers to deliver products effectively and maintain a competitive edge. However, there are always ways to improve innovation, speed to market and data quality while continuing to be compliant.