Market Access

ECRI Warns 70% of KN95 Masks from China Don’t Meet Standards, Puts Healthcare Workers at Risk

By Maria Fontanazza, Editor-in-Chief

The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.

Telemedicine Cybersecurity Report:
iOS Patient-Facing Mobile Apps

Sponsored By Irdeto

In this white paper, Irdeto identified five popular patient-facing iOS telemedicine mobile apps that offer on-demand virtual visits direct to customers through the App Store and performed an extensive cybersecurity threat risk analysis of these apps.

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Regulatory

FDA Establishes Digital Health Center of Excellence

By MedTech Intelligence Staff

The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.

Business Analysis

EU MDR Strategy:
How to Effectively Deploy Consultant Partnerships

By Chad Reynolds, Maetrics

Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.

Market Access

MEDICA and Compamed 2020 Go Virtual

By MedTech Intelligence Staff

Global travel restrictions proved it impossible to hold the event in-person.

Regulatory

Medical Device Recall Activity at Highest Levels in Two Years, Is COVID-19 Responsible?

By Maria Fontanazza

Medical device recalls were up more than 31% during Q2 2020, activity that suggests recalls will reach 1200 by the end of the year, according to Stericycle’s latest recall report.

Potential Claims and Defenses

Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.

Five Lessons from Past Product Misdiagnosis Cases

Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.

Featured Quote

With cities and businesses reopening across the United States, physicians predict telemedicine will play an integral role in healthcare moving forward, as long as the changes made by the government to ease restrictions and regulations enabling telehealth are permanent.

— Greg Kahn, Internet of Things Consortium

Securing devices so that clinicians and patients connect without fear.

Sponsored By Irdeto

Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps

Sponsored By Irdeto

The engineer’s guide to wearables

Sponsored By 3M

Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

Sponsored By Evidera

The Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

• Medical Device Audits, Certification & Verification
• Quality & Regulatory Market Access Solutions
• Medical Device Component
  sponsored by 3M
• Medical Recall