2021 - Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations

MedTech Intelligence

Volume 12 Issue No. 30

 

Market Access

Shipments of COVID-19 Diagnostic Tests Top 1 Million DailyShipments of COVID-19 Diagnostic Tests
Top 1 Million Daily

By MedTech Intelligence Staff

AdvaMed’s Diagnostic Supply Registry is tracking the progress of molecular diagnostic tests to help support state and federal governments.

 

Economic Operators under EU MDR

Featured Articles

Regulatory

LabCorpLabCorp Wins Reissued EUA for COVID-19 Test,
First to Test Asymptomatic Population

By MedTech Intelligence Staff

The authorization is a step toward broad screening that will help reopen schools and workplaces in America, says FDA Commissioner Stephen Hahn, M.D.

Postmarket Surveillance and Postmarket Clinical Follow-Up Webinar

Technology

Greg Kahn, Internet of Things ConsortiumHow COVID-19 May Be the Catalyst in Ensuring a Healthy Future for Telemedicine

By Greg Kahn, Internet of Things Consortium

With everything to gain, telehealth may lead to a new standard in health/wellness treatment while at the same time unifying the entire healthcare ecosystem.

MedTech Library

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

Sponsored By Evidera

Gone are the days of selling med tech products to surgeons and physicians based on relationships alone. Today, surgeons must convince hospitals that a new product provides clinical and economic value, and manufacturers must arm surgeons with evidence to facilitate successful discussions with hospital value-analysis teams (VAT).

Read More!

The Growing Need for Real-World Evidence in Medical DevicesThe Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

Derived from a wide range of data sources, real-world evidence (RWE) is used to complement clinical trial data to create a robust evidence base showing both safety and efficacy in defined populations (clinical trials), as well as outcomes in the general populations.

Read More!

Software and Digital Health under EU MDR Webinar

EU MDR

By Beth Crandall, MaetricsEconomic Operators: New Responsibilities Shake Up MedTech

By Beth Crandall, Maetrics

One ill-prepared EO can impact the entire supply chain.

2nd Annual Legacy Medical Device Cybersecurity Conference - A Virtual Event - September 22 - 23, 2020

Technology

Roger Sands, Wyebot, Inc.Optimizing Wireless Networks in Nursing Homes
and Care Communities

By Roger Sands, Wyebot, Inc.

Networks enable the use of critical resources, including telehealth services, medical IoT technology,and staff and personal devices. It is critical to have a reliable WiFi network to support these devices.

Designing Instructional Materials to Support Health Literacy for FDA Submissions Webinar

Upcoming Events & Webinars

AugAugust 20, 2020 - 1:00 p.m. - 2:00 p.m. ET - 
2021 – Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations
Complimentary Webinar

SeptemberSeptember 2, 2020 - Economic Operators under EU MDR
A Virtual Event

SeptemberSeptember 9, 2020 - Postmarket Surveillance and Postmarket Clinical Follow-Up
A Virtual Event

SeptemberSeptember 16, 2020 - Software and Digital Health under EU MDR
A Virtual Event

SeptemberSeptember 22 - 23, 2020 - 2nd Annual Legacy Medical Device Cybersecurity Conference
A Virtual Event

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

Resource Centers

Resource Centers are single topic focused micro-sites within MedTechIntelligence.com 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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