MedTech Intelligence Volume 9 Issue 38

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	Volume 9 Issue No. 38

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

Practical Risk Management - November 8-9, 2017 - Washington, DC

Featured Articles

Sara E. Dyson, Esq., Medmarc Medical Device Software & Products Liability:
An Overview (Part I)

By Sara E. Dyson, Esq., Medmarc

How software is changing the legal landscape for medical device manufacturers.

Sponsored by:

"The new MDR will bring about a number of changes that manufacturers need to be thinking about immediately, if they haven’t already begun."

"The warning letter used in support of this week’s guidance contained a total of eight Form 483 observations, a number that usually results in the awarding of that prized FDA Warning Letter."

"Each year, Boston Scientific’s products treat more than 24 million patients worldwide in markets that are expected to exceed $50 billion by 2020."

"Critical factors in decisions driving the operations and management of the company must be evaluated as risk and opportunistic (or risk/benefit) driven outcomes."

"Serving alongside Zimmer Biomet’s dedicated employees over the past 16 years and leading the Company as CEO for ten of those years has been a privilege and a highlight of my professional career."

Compamed - November 13-16, 2017 - Düsseldorf, Germany

Making UDI Tracking Part of Your Systems - September 26, 2017 - 1:00pm EDT

Medical Device Cybersecurity Workshop - October 17-18, 2017 - Boston, MA

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

Sponsored Resources

COMPAMED 2017: INTERNATIONAL TRADE SHOW FOR MEDICAL TECHNOLOGY SECTOR

COMPAMED, High tech solutions for medical technology, will return to the fairgrounds in Düsseldorf, Germany from November 13 – 16, 2017. This trade show has developed into the leading international marketing platform for suppliers in the medical technology industry and will feature about 800 exhibitors from around the globe. Held concurrently with MEDICA, World Forum for Medicine, both events attract about 128,000 visitors every year and present the entire process chain and full range of medical products, devices and instruments.

Be part of it!

Southeast Computer Solutions Making UDI Tracking Part of Your Systems

Medical Device Manufacturers need better systems to be able to comply with new regulations whether you’re talking about ERP or QMS validation for the FDA (i.e. 21 CRP Part 11, and Part 820), Unique Device Identification traceability, high-read-rate bar codes, or product liability insurance. All these areas carry enormous costs and risks if done incorrectly. This webinar looks at how to develop a systems roadmap and implementation strategies for UDI's.

Join Us! September 26 @ 1:00pm EDT

Upcoming Events & Webinars

October 17-18, 2017 - Medical Device Cybersecurity Workshop

Boston, MA

November 2-3, 2017 - China: The MedTech Market

Washington, DC

November 8-9, 2017 - Practical Risk Management throughout the Product Life Cycle

Washington, DC

Q4 2017 - Combination Products: A Conference for Drug, Device, Diagnostics, & Biologics Manufacturers

Washington, DC