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MedTech Intelligence

Volume 16 Issue No. 13


Philip Remedios, BlackHägen DesignNavigating the New Normal:
Achieving R&D Success in Hybrid Work Environments

By Philip Remedios and Renée Bailey, BlackHägen Designs

Implementing a hybrid work environment with R&D teams yields significant benefits but also presents challenges. In this article, we explore how to achieve successful R&D programs within the context of hybrid environments, and share key strategies and best practices to effectively navigate the challenges, including the safeguarding of sensitive information and data.


Medical Device Regulatory Intelligence Summit
Digital Transformation & the Everchanging Regulatory Landscape

June 3-5, Washington DC

3 days of Industry Intelligence, Case Studies, and Networking with Industry Leaders.

Day 1: Hands-on pre-conference workshops

    • Companion Diagnostics Regulations & Requirements in Asia
    • Leveraging Post-Market Clinical Follow-Up (PMCF) Data to Improve Safety & Performance Monitoring
    • Navigating the Transition of Medical Device Quality Management – FDA QMSR & ISO 13485
    • EU MDR deadlines have passed, where you can sell your device abroad?

Day 2: Regulatory Intelligence & Digital Transformation: understand key trends, challenges, and solutions impacting MedTech regulatory processes and MedDevice compliance.

Day 3: Regulatory Efficiency: Global Compliance Intelligence, Strategies & Execution by Region.

Register now


Featured Articles

FDA Proposes to Ban Electrical Stimulation Devices

By MedTech Intelligence Staff

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

IQ OQ PQ and Its Role in Labeling System Validation

By Nick Recht, TEKLYNX

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRdH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

Flex - Creating the extraordinary in medical products, together.

Stryker Completes Acquisition of SERF SAS

By MedTech Intelligence Staff

With more than 50 years in the medical device space, SERF SAS is recognized for its innovations in hip implants, including the invention of the original Dual Mobility Cup.

Abiomed Updates IFU for Impella Left Sided Blood Pumps Due to Perforation Risks

By MedTech Intelligence Staff

Use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. To date, there have been 129 reported serious injuries, including 49 reports of death.

Breath-based Analysis:
Revolutionizing Disease Screening for a Healthier Tomorrow

By Karim Aly, Noze

Traditional screening tests suffer from a range of challenges. From logistical barriers to concerns regarding accuracy and reliability, achieving accurate diagnosis is frequently arduous. Imagine a revolutionary approach where early disease screening becomes as simple as collecting a breath sample. Thanks to cutting-edge sensor technology and advanced artificial intelligence, this vision is now on the brink of realization.

Essenvia - The Platform That Enables Regulatory Excellence


Addressing engineering challenges in point-of-care diagnostic devicesAddressing engineering challenges in point-of-care
diagnostic devices

Discover what to consider when designing and manufacturing point-of-care diagnostic devices, including ensuring measurement accuracy and reliability, user-friendly operation, and scalable production with validated manufacturing processes.

Download to learn more

MedTech Intelligence's Regulatory Intelligence & Networking Summit - June 3-5, 2024 - Washington, DC

Upcoming Events & Webinars

April 9, 2024 - 2:00PM - 3:00PM ET

Japan Medical Device Registration & Reimbursement

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