MedTech Intelligence Volume 9 Issue 21

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	Volume 9 Issue No. 21

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

Featured Articles

Optimize Combination Products:
Select a Drug Delivery Device that Meets User Needs

By Allison Strochlic and Erin Davis, UL-Wiklund

The device should be carefully matched to end users, rather than be an afterthought.

This Week’s Recalls

Abbott Abbott Initiates Voluntary Recall of Coronary Catheters

By MedTech Intelligence Staff

The issue involves problems removing the balloon sheath during cardiac procedures.

Respironics Recalls Ventilator Due to Unexpected Shutdown

By MedTech Intelligence staff

A vibration issue could cause the device to stop therapy.

Featured Quote

Every supplier is going to have a problem—it’s how you respond to the problem. We ask you to share your recall process with us.

— Terri Nelson, Mayo Clinic

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International What, No Inspection Results?

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

Documentation proves compliance, including when it comes to acceptance activities.

MEDICA 2017 Wanted:
Innovative Medical Mobile Solutions for Competition

By MedTech Intelligence Staff

Developers from around the world can submit their mobile medical solution to the MEDICA App Competition.

Barcoding in the NHS and the run-up to UDI Barcoding in the NHS
and the run-up to UDI

By Peter Rose, Maetrics

UK and European manufacturers should put a UDI implementation plan in place ASAP.

Sponsored Content

Will your Notified Body be Prepared for the EU MDR? UL is.

There have been several articles about how much additional work and pressure the Notified Bodies must go through to meet the new IVDR and MDR. As a Notified Body for the MDD and IVDD, UL is well prepared to support new customers with Notified Body certification. We have a full-time team with medical expertise and regulatory experience to add value to your ability to get the CE Mark. We’ve taken their collective experience and created a list of considerations when selecting a Notified Body.

The New EU Medical Device & IVD Regulations - July 26-27, 2017 - Washington, DC

Premarket Solutions Workshops - 3 Days, 3 Workshops, 3 Cities.

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

Evaluation of Wear Time for Various Tapes on Human Volunteers:
8-day Study

Download your copy of Evaluation of Wear Time for Various Tapes on Human Volunteers: 8-day Study to understand challenges when adhering to human skin. As a device manufacturer, your key consideration when selecting a tape is ensuring proper adhesion to the patient’s body. Whether it’s affixed for several hours, a day or even a week, your device needs to stay attached to do its job. While adhesion is critical, there are other factors that need to be considered.

Upcoming Events & Webinars

July 18, 19, 20, 2017 - Premarket Submissions

Washington, DC

July 26-27, 2017 - The New EU Medical Device & IVD Regulations

Washington, DC

Q3 2017 - Medical Device Statistics for Non-Statisticians

Washington, DC

October 23, 24, 25, 2017 - Premarket Submissions

Menlo Park, CA

December 4, 5, 6, 2017 - Premarket Submissions

Schaumburg, IL

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

Washington, DC