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MedTech Intelligence

Volume 9 Issue No. 01

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

Accumold

Featured Articles

FDA Releases Final Guidance on Postmarket CybersecurityFDA Releases Final Guidance on Postmarket Cybersecurity

By MedTech Intelligence Staff

Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.

Krish Kupathil, MobiliyaFix It Faster, Save Lives:
Augmented Reality for
Medical Equipment

By Krish Kupathil, Mobiliya

AR is a key driver for operational and maintenance efficiency, as well as productivity.

FDAWhat Guidance Documents Will CDRH Issue in 2017?

By MedTech Intelligence Staff

FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.

Top 10 2017 IssuesTop 10 2017 Issues

By MedTech Intelligence Staff

Will the ACA be repealed under the new administration? How will industry navigate the challenging reimbursement environment?

 
 

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Bad News for a Device Establishment

By Christopher Devine, Ph.D.,
Devine Guidance International

Have repeat observations from a previous inspection? Expect a warning letter.

CDRH to Post Recall Information EarlierCDRH to Post Recall Information Earlier

By MedTech Intelligence Staff

The center is changing its communication on recalls to minimize confusion among healthcare providers and patients.

 

More Articles »

 
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Sponsored Resources

Clinical Trials for Medical Products in JapanClinical Trials for Medical Products in Japan

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Upcoming Events & Webinars

February, 2017February 15-16, 2017 - Process and Test Method Validation for Medical Devices

Virtual

February, 2017February 28-March 1, 2017 - Global Regulatory Strategy

Washington, DC

March, 2017March 1-2, 2017 - FDA Advisory Panels: A Workshop for Medical Device Companies

Washington, DC

March, 2017March 7-8, 2017 - Remediation of Medical Device Quality Systems

Washington, DC

March, 2017March 21-22, 2017 - Medical Device Software

Washington, DC

March, 2017March 23-24, 2017 - Medical Device Cybersecurity

Washington, DC

April, 2017March/April 2017 - Medical Device Statistics for Non-Statisticians

Washington, DC

May, 2017May 2017 - HHE and Recalls: FDA & Industry Procedures & Practices

Washington, DC

June 2017 - Combination Products: A Conference for Drug, Devide, Diagnostics, & Biologics Manufacturers

Washington, DC

 
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