The New EU Medical Device and IVD Regulations: Requirements and Strategies for Efficient Compliance - A Virtual Conference - August 29-30, 2017

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MedTech Intelligence

Volume 9 Issue No. 33

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

Ameing for Asia

Ames Gross, Pacific Bridge MedicalFour Reasons to Source and Manufacture Medical Supplies
in Asia

By Ames Gross, Pacific Bridge Medical

Cost savings and the ability to meet high-volume demands are enticing benefits.


Emmanuel Garnier, Simmons & Simmons, LLPWhen Health-Related Apps Qualify as Medical Devices
in the European Union

By Emmanuel Garnier
Simmons & Simmons, LLP

According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.


Mona Orady, M.D., Dignity HealthWe Need to Come Together to Learn Complex Surgery

By Mona Orady, M.D., Dignity Health

There is still much to learn about the benefits and potential of robotic surgery.

FDA Issues Alert on Intragastric BalloonsFollowing Reported Deaths,
FDA Issues Alert on Intragastric Balloons

By MedTech Intelligence Staff

The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Is Dr. D Listed on Your Approved Supplier’s List?

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

For all of you CJOs out there, the FDA will never feel a tinge of schadenfreude when writing a boatload of Form 483 observations during an inspection. It is their job to investigate and document compliance issues and concerns.

Sponsored Content

5 Things Everyone Should Know
about Micro-Molding

With the pressure on design engineers to deliver smaller, lighter and more cost-effective components many are turning to micro injection molding for support. Challenges often arise when designing for micro molding that can present unforeseen road blocks. Questions like – What is micro molding? How is it different from standard molding? Or, what do I need to know to be successful at molding a micro plastic part? - are commonly asked by engineers. Download 5 Things Everyone Should Know about Micro-Molding to learn the answers to these and other questions.


More Articles »

Medical Device Recalls - Offered in Coral Gables, FL AND San Francisco, CA in October
Sponsored Resources

Compamed 2017: International Platform 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 fair 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!

Upcoming Events & Webinars

August, 2017August 29-30, 2017 - The New EU Medical Device & IVD Regulations

A Virtual Conference

Oct. 2017October 11-12, 2017 - Medical Device Recalls

Coral Gables, FL

Oct. 2017October 12-13, 2017 - Medical Device Statistics for Non-Statisticians

Coral Gables, FL

Oct. 2017October 17-18, 2017 - Medical Device Cybersecurity Workshop

Boston, MA

Oct. 2017October 23, 24, 25, 2017 - Premarket Submissions

Menlo Park, CA

Oct. 2017October 26-27, 2017 - Medical Device Recalls

Menlo Park, CA

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

Washington, DC

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

Washington, DC

November 2017November 29, 30, December 1, 2017 - Premarket Submissions

Schaumburg, IL

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

Washington, DC

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