MedTech Intelligence Volume 9 Issue 08

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	Volume 9 Issue No. 08

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

Featured Articles

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Refuse Facility Access to FDA and Bad Things Happen

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

Denying the agency to inspect your facility is a violation.

What's Your ISO 13485 IQ? What's Your ISO 13485 IQ?

By MedTech Intelligence Staff

In Part I of our ISO 13485 test, see how much you know about the basics of the standards.

Was Device Tax Responsible for 29k Job Loss? Was Device Tax Responsible for 29k Job Loss?

By MedTech Intelligence Staff

The U.S. Department of Commerce reported a 7.2% decline in jobs in the medical device industry.

Linda M. Chatwin, Esq, RAC, UL, LLC Laura Elan, UL, LLC Build an Effective Global Regulatory Strategy

By Laura Elan and
Linda M. Chatwin, Esq, RAC,
UL, LLC

Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.

Featured Quote

ABUS enables physicians to screen women, especially with denser breasts, and provides superior image quality, giving the products a competitive edge over handheld ultrasound systems (HHUS).

— Saurabh Shah, Cubex

Integra LifeSciences to Acquire J&J’s Codman Neurosurgery

By MedTech Intelligence Staff

The deal is pending acceptance by Johnson & Johnson.

Laura Johnson, Loftware 5 Labeling Trends
Affecting MedTech

By Laura Johnson, Loftware

How the shifting supply chain landscape and regulatory requirements will impact your business.

Recall High Fracture Rate:
Zimmer Biomet Recalls Reverse Shoulder

By MedTech Intelligence Staff

The shoulder replacement is used on patients with rotator cuff tears.

FDA Advisory Panels - February 28 - March 1, 2017 - Washington, DC

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

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

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

Sponsored Resources

3M - Download brochure here. Quality Materials. Trusted Expertise.

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A Best Practices Guide to GMP Compliance Management Systems

Download the complimentary white paper.

When it comes to choosing a GMP Compliance Management system for your organization, there is much to consider. With so many different options out there, it may be difficult to determine which one will provide the most value and prove to be truly. Learn some of the features of an effective GMP compliance system as well as the best practices that should be built into the system to ensure an effective process.

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Upcoming Events & Webinars

February 28-March 1, 2017 - Global Regulatory Strategy