Designing Instructional Materials to Support Health Literacy for FDA Submissions Webinar

MedTech Intelligence

Volume 12 Issue No. 38


Market Access

ECRI Warns 70% of KN95 Masks from China Don’t Meet StandardsECRI 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.



Crescent IndustriesTelemedicine 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.

Read More!

Featured Articles


FDAFDA 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 VirtualMEDICA and Compamed 2020 Go Virtual

By MedTech Intelligence Staff

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


Maria FontanazzaMedical 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.

Liability Risks and Litigation Defenses for COVID-19 TestsPotential 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.

Upcoming Events & Webinars

SeptemberSeptember 30, 2020 - Designing Instructional Materials to Support Health Literacy for FDA Submissions
A Virtual Event

NovNovember 18-20, 2020 - Computer Modeling & Simulation in MedTech Product Development & Submissions
A Virtual Event

Resource Centers

Resource Centers are single topic focused micro-sites within that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

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