MedTech Intelligence Volume 10 Issue 50

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	Volume 10 Issue No. 50

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

FDA Encourages Innovation and Safety FDA Encourages Innovation and Safety as Part of
Medical Device Regulatory Overhaul

By Amy Scanlin, EAS Consulting Group, LLC

The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.

Featured Articles

Maria Fontanazza, Editor-in-Chief First Step in EU MDR Compliance: The Gap Analysis

By Maria Fontanazza, Editor-in-Chief

A gap assessment provides a toolbox for the decision-making process.

Soapbox

Bryan Brosseau, Brosseau Consulting, LLC EU MDR Post-Market Surveillance: Active, Integrated, Risk-Based,
and Planned

By Bryan Brosseau,
Brosseau Consulting, LLC

Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.

Ameing for Asia

Ames Gross, Pacific Bridge Medical Western Companion Diagnostic Firms Gain Foothold in the Japanese Market

By Ames Gross, Pacific Bridge Medical

This mode of personalized medicine helps doctors make more informed decisions related to drug therapies.

Brian Ochs, 3M Medical Materials and Technologies Five Stages to Bringing a New Medical Device to Life

By Brian Ochs,
3M Medical Materials and Technologies

While the road to bringing a medical device to market is often bumpy, working with an experienced and knowledgeable partner can help navigate the process and potentially avoid some of the bumps.

Featured Quote

As we blend medical technology with consumer technology, I foresee the De Novo program being utilized by companies such as Fitbit and Garmin. As a consumer, I’m very excited for the potential and advancements.

— Jon Speer, Greenlight Guru

FDA FDA Commish and CDRH Director Announce Agency Actions to Enhance Patient
Safety Using Data

By MedTech Intelligence Staff

The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.

Sponsored Content

Crescent Industries 4 Keys to Sourcing Quality & Cost Effective Medical Injection Molding

The stakes are high when building and deploying medical devices used to treat patients and their illnesses around the globe. Thus when manufactures are sourcing their injection molds for parts needed in their devices, the most pressing concern must be to first identify suppliers with proven track records of success and that are fully equipped with excellent facilities, quality controls and specialized personnel. Learn how Crescent Industries can help you.

Medical Device Process Validation: A Virtual Conference - January 29-30, 2019

Advanced CAPA & Root Cause Analysis Conference - January 23-24, 2019 - 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
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall

Sponsored Resources

The Regulatory Consultant's Guide to ISO 10993-1

Join WuXi AppTec in a must-see webinar with their regulatory experts, Sandi Schaible, senior director of analytical chemistry, and Mark Cabonce, director of technical & regulatory, to learn the ins and outs of ISO 10993 Part 1, as well as best practices and what to be aware of when analyzing a chemistry report.

Upcoming Events & Webinars

January 23-24, 2019 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

January 29-30, 2019 - Medical Device Process Validation
A Virtual Conference

March 5-6, 2019 - EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact
Washington, DC

March 6-7, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

April/May, 2019 - Med Tech Import/Export
Washington, DC

April/May, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

April 11-12, 2019 - EU IVDR Implementation
Washington, DC

May 7-8, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Cambridge, MA

May 21-22, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June, 2019 - Global Regulatory Strategy
Washington, DC