MedTech Intelligence Volume 10 Issue 21

Get Your FREE Subscription Here! About Us
	Volume 10 Issue No. 21

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

Featured Articles

Soapbox

Jon Speer, Greenlight Guru Understanding FDA’s Guidance on Medical Device Reporting

By Jon Speer, Greenlight Guru

How in touch are you with current MDR guidelines?

Ames Gross, Pacific Bridge Medical Liver Disease:
A Growing Problem in Asia

By Ames Gross, Pacific Bridge Medical

Although pharmaceuticals are the main treatment route, medical devices are needed to fight the disease on a new level.

Medtronic Recalls
MindFrame Capture LP Revascularization Device

By MedTech Intelligence Staff

There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.

Featured Quote

Rapid technology advances in molecular techniques, processing, throughput, miniaturization and cost of imaging technologies suggest that infectious disease diagnostics will also undergo rapid advances.

— Nick Allan, Starfish Medical

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Company Ignores FDA’s
Request to Cease Commercial Distribution

By Dr. Christopher Joseph Devine,
Devine Guidance International

When FDA says stop, they mean stop!

Soapbox

Laura Johnson, Loftware Emerging Trends and Opportunities in Medical
Device Labeling

By Laura Johnson, Loftware

Innovations are helping companies to maintain compliance while driving operational gains across their supply chain.

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
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall

Sponsored Resources

Does your Clinical Evaluation Report comply with EU requirements?

We can help. Preparing a compliant clinical evaluation report (CER) requires time and experience, especially in this strict regulatory environment. Emergo consultants are experts in CER preparation to MEDDEV 2.7/1 rev 4 and the Medical Devices Regulation (MDR). Learn how we can help with this important regulatory requirement for Europe.

Upcoming Events & Webinars

September 13-14, 2018 - MedTech Product Claims - What Can You Say?
Washington, DC

September 17-18, 2018 - Medical Device Process Validation Virtual Conference
Washington, DC

October 22-23, 2018 - MedTech Mergers & Acquisitions Conference
Washington, DC

October 24, 2018 - Medical Technology: Import/Export Workshop
Washington, DC

November 27-28, 2018 - Global Strategies for Combination Products Conference
Washington, DC

November 29-30, 2018 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

Q1 2019 - Digital Health Technologies Conference
Silicon Valley, CA

Q1 2019 - Medical Cybersecurity - Remediation of Legacy Medical Devices
Silicon Valley, CA

Q1 2019 - MedTech Innovation Mergers & Acquisitions Workshop
Silicon Valley, CA