Soapbox

Big Data and Post Market Surveillance of Medical Devices

By John Wilkinson and Mark Wasmuth, GMDN Agency

For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.

FDA Launches EtO Sterilization Master File
Pilot Program

By MedTech Intelligence Staff

The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.

Survey: 75% MedTech Pros Unprepared for an Unannounced FDA or
Notified Body Audit

By MedTech Intelligence Staff

The report also found that medical device companies are taking “huge gambles” in the area of risk management.

How Are Medical Device Companies Addressing
EU MDR?

By Laura Johnson, Loftware

With the next major milestone for EU MDR fast approaching, many medical device companies are finding they need to make some quick decisions to address the range of issues presented by this looming deadline.

Featured Quote

IoT technologies can help monitor and notify caregivers, and alert healthcare providers with actual real-time data to identify issues before they become critical to allow for earlier intervention.

— Janet Ooi Keysight Technologies

Soapbox

Sepsis:
We Need Technologies that More Effectively Treat Patients

By Kumar Sharma, M.D.
UT Health San Antonio

Each year, more than 250,000 Americans die from the common and deadly condition.

MEDdesign

Innovative Technologies Help Battle Nation’s Chronic Liver Disease Epidemic

By Jon Gingrich, Echosens North America

The adoption of accurate non-invasive measures of liver health at the point of care is critical.

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

EU MDR: REQUIREMENTS & IMPLEMENTATION

THIS EVENT WAS RECORDED JULY 17, 2019 | On Demand Webcast

This on-demand recording of the four-hour virtual event that took place July 17, 2019, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes. The four hour webcast recording is $495.00

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ADVANCED CAPA & ROOT CAUSE ANALYSIS

THIS EVENT WAS RECORDED MARCH 26-27, 2019

CAPA is the most critical and challenging quality system requirement in terms of complex thinking and organizational processes. How do you verify effectiveness? How can you apply project management to CAPA? What are the right data and tools for identifying trends? How do you deal with significant but infrequent problems? Should you set deadlines for closing CAPAs, and what about CAPAs that never close? What are best practices for documenting and communicating CAPA results? Not a CAPA 101 course, this workshop recording brings together leading industry CAPA process owners to discuss approaches to the most difficult problems in CAPA and root cause analysis.

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