Volume 9 Issue No. 32
Optimize Combination Products:Select a Platform Drug Delivery Device that Reflects Good Human Factors Engineering
By Erin Davis and Allison Strochlic, UL-Wiklund
A guide to the steps companies can take to evaluate their device developer’s HFE process.
Double Win:Medtronic Receives FDA Approval and CE Mark for Aortic Valve
By MedTech Intelligence Staff
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
Is Dr. D Listed on Your Approved Supplier’s List?
By Christopher Devine, Ph.D.,Devine Guidance International
Device establishments must maintain records of acceptable suppliers.
Our device employs the latest photonics technology, allowing a user to make measurements of the vibration characteristics of the heart without even touching it.
— Mirko de Melis, CARDIS
Protecting Networks and Rapidly Treating Patients a Balance in Cybersecurity
The healthcare ecosystem needs to be more proactive in managing cybersecurity risks.
IQ, OQ and PQ:The Backbone of Your Quality System
By Edward Simpson, RS Calibration, Inc.
Know how IQ, OQ and PQ–the three essential elements of a Quality Assurance System–govern the medtech sector.
FDA’s Innovation Initiative Aims to Prevent Regulatory Barriers
The agency wants to modernize its regulatory processes and make them more efficient.
More Articles »
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.
August 29-30, 2017 - The New EU Medical Device & IVD Regulations
A Virtual Conference
October 11-12, 2017 - Medical Device Recalls
Coral Gables, FL
October 12-13, 2017 - Medical Device Statistics for Non-Statisticians
October 17-18, 2017 - Medical Device Cybersecurity Workshop
October 23, 24, 25, 2017 - Premarket Submissions
Menlo Park, CA
October 26-27, 2017 - Medical Device Recalls
November 2-3, 2017 - China: The MedTech Market
November 8-9, 2017 - Practical Risk Management throughout the Product Life Cycle
November 29, 30, December 1, 2017 - Premarket Submissions
Q4 2017 - Combination Products: A Conference for Drug, Device, Diagnostics, & Biologics Manufacturers