MedTech Intelligence Volume 10 Issue 01

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	Volume 10 Issue No. 01

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

Featured Articles

Ameing for Asia

Ames Gross, Pacific Bridge Medical Update on Radiology Market
in China

By Ames Gross, Pacific Bridge Medical

Economic development in China has created a burgeoning middle class that demands higher standards of living.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International What, No Installation Records?

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

FDA expects all installation activities to be documented.

Featured Quote

Ransomware and other types of malicious software programs (malware) can disrupt healthcare delivery operations, hindering the delivery of care and putting patients at risk.

— ECRI

Stephanie Kute, Battelle How "Big Data" Enabled
a Paralyzed Man to
Move His Arm

By Stephanie Kute, Battelle

How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?

Lack of Adequate CAPA Procedures Lack of Adequate CAPA Procedures Tops FDA’s
List of Violations

By MedTech Intelligence Staff

The agency has issued its list of the most common inspectional observations for FY 2017.

FDA CDRH Launches Manufacturing and Product Quality Pilot Program

By MedTech Intelligence Staff

The program intends to promote quality in medical device design and manufacturing.

Sponsored Content

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Medical Device Statistics for Non-Statisticians - February 13-14, 2018 - A Virtual Conference

Contact Marc Spector about MTI advertising programs.

Resource Centers

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.

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

Upcoming Events & Webinars

January 23-24, 2018 - Premarket Submissions: 510(k) and de Novo Pathways to Market
A Virtual Conference

February 6-7, 2018 - Premarket Submissions: PMA Submissions Workshop
A Virtual Conference

February 13-14, 2018 - Medical Device Statistics for Non-Statisticians
A Virtual Conference

February 20-21, 2018 - Premarket Submissions: FDA Submissions Strategy
A Virtual Conference

March 6-7, 2018 - New Concepts in Risk Management
Washington, DC

March 26-27, 2018 - Cybersecurity Vulnerability Management
Washington, DC

March 26-27, 2018 - Cybersecurity Patch Management
Washington, DC

Second Quarter, 2018 - Cybersecurity: Remediation of Legacy Devices
Washington, DC

April 2018 - China – the MedTech Market
Boston, MA

May 14-15, 2018 - HHE & Recalls
Washington, DC

June 14-15, 2018 - MedTech Regulatory Summit
U.S. Pharmacopeia - Rockville, MD

June 26-27, 2018 - Developing Appropriate Medical Technology
Carolinas HealthCare System - Charlotte, NC