Soapbox

New Technologies Tackle Big Global Health Threats

By Robert Ward, ExThera Medical

Treatment can no longer be one dimensional.

FDA "First" Approvals:
Pediatric Lens for Myopia and Duodenoscope with Disposable Elevator

By MedTech Intelligence Staff

CooperVision, Inc. and Pentax of America won the agency approvals, respectively.

Survey Shows Return of Medical Device Tax Will Cause Job Losses

By MedTech Intelligence Staff

AdvaMed states that the huge tax increase will have a significant impact on employment and investment.

Featured Quote

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.

— Laura Johnson Loftware

Making Way for Probability in Human Factors (Part I)

By Nicholas Zampa, Independent Scholar

This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.

Making Way for Probability in Human Factors (Part II)

By Nicholas Zampa

Part II of this series proposes that structured expert judgment, when integrated into the current HFE/UE paradigm, can help overcome some of the current limitations of HFE/UE.

Designing Medical Devices for Dignity

By Bryce Rutter, Ph.D., Metaphase Design Group, Inc.

Aging is not for the faint of heart.

• 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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