FDA Signals Change in Health IT Compliance Direction
By: Ellyn McMullin, Research Associate Jeffrey Shuren, M.D., J.D., Director, Center for Devices & Radiological Health spoke at the public workshop “Proposed Risk-Based RegulatoryRead More...
View ArticleExecutives Offer Prospects for Med-Tech Business Model
By Daniel R. Matlis I recently had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: AdviceRead More...
View ArticleFDA Forum Fosters Candid Discussion Between Industry and Agency
By Daniel R. Matlis On June 26, the FDA hosted an Executive Forum on the “Case for Quality Initiative.” The forum brought together IndustryRead More...
View ArticleWhat Changes Should Manufacturers Expect From FDA?
By Daniel R. Matlis I recently had the privilege to moderate a panel entitled: “Outlook for the Medical Device Industry 2014 and Beyond: AdviceRead More...
View ArticleIBM puts Watson to work at Johnson & Johnson and Sanofi R&D
By Ellyn McMullin, Research Associate, Axendia, Inc. Three years after its victory on the TV quiz show Jeopardy! IBM Watson has evolved to representRead More...
View ArticleNew Report: FDA’s Executive Forum on the “Case for Quality Initiative”
by Axendia Staff FDA’s Executive Forum on the “Case for Quality Initiative” brought together Industry Executives, FDA Officials and Industry Advisors in a seriesRead More...
View ArticleMed-Tech CEO’s turn to Emerging Markets for Double-Digit Growth
By Daniel R. Matlis Med-Tech Companies are poised to capitalize on global opportunities; however, they must balance the risks and rewards of globalization. WhenRead More...
View ArticleThe Loving Heart Behind the Living Heart Project
By Daniel R. Matlis “The 3DExperience” was at the core of Dassault Systèmes user’s conference in Las Vegas last month. “We are at theRead More...
View ArticleCompliance-First Approach Still Obstacle to Product Quality
After Five Years, Compliance-First Approach Still Obstacle to Improving Product Quality SUMMARY Five years ago we looked at the road blocks to improving productRead More...
View ArticleInnovation on a Global Scale. Are you Ready?
Quality, Regulations, Design and the Patient Experience By Sandra Rodriguez, Research Associate, Axendia Med-Tech companies are at an innovation crossroads. They must seek newRead More...
View ArticleFDA DELAYED ENFORCEMENT OF DQSA REQUIREMENTS
Delayed Enforcement Provides a Business Opportunity By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia On July 1st, FDA published guidance statingRead More...
View ArticleFood for Thought on Quality and Compliance
By Daniel R. Matlis Would you rather… Eat Bad Food in a Clean Restaurant? OR Eat Great Food in an Unsanitary Restaurant? I sharedRead More...
View ArticleThe Race for Your Wrist and Medical Data is Happening – Now!
By Sandra Rodriguez Technology and Life Science companies are collaborating at full speed 2015 is turning out to be an interesting year in theRead More...
View ArticleFDA Delayed Enforcement of DQSA Requirements – Part II
By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia Delayed Enforcement Provides Opportunity to Develop Complimentary Systems The FDA’s delayed enforcement ofRead More...
View ArticleISPE, FDA and the Metrics Future
By David R. Somers, Senior Industry Analyst, Axendia Manufacturers and FDA to Measure Product Quality Summary The continuing efforts by biologic and pharmaceutical manufacturersRead More...
View ArticleIntelligence Based E-Inspections
By Daniel R. Matlis, President, Axendia Are You Ready to be Graded on a Curve? Summary The Food and Drug Administration Safety and InnovationRead More...
View ArticleFDA and Industry Embrace Highest Quality for Medical Products
By: Daniel R. Matlis, President Historically, interactions between industry and the FDA have been described as complex, challenging and even adversarial. Many a time,Read More...
View ArticleDoes Playing by the Rules Guarantee a Win?
By Daniel R. Matlis Is Your Team Focused on Quality or Compliance? Super Bowl 50 was right around the corner when we gathered inRead More...
View ArticleWebinar Announcement hosted by FDANews
Managing Quality and Compliance in a Global and Outsourced Ecosystem Please join Axendia and Veeva Systems for a complimentary FDANews webinar on March 30thRead More...
View ArticleNew FDA Commissioner Adamant About Unique Device Identifiers (UDI)
By: Ellyn McMullin, Research Associate and Daniel R. Matlis, President UDI Implementation – The Key to Unlock Personalized Medicine? The Senate has confirmed CardiologistRead More...
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