MedTech Intelligence Volume 10 Issue 49

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	Volume 10 Issue No. 49

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

EU MDR Misconceptions of EU MDR Implementation

By Maria Fontanazza, Editor-in-Chief

Lack of preparation and understanding of the efforts required to comply with the regulation will hinder product launches, negatively impact sales, and hurt a company’s reputation.

Featured Articles

Soapbox

Alana McGolrick, PeriGen AI-Driven Technology Reduces Risks Associated with Labor by Providing A Second Set of Eyes

By Alana McGolrick, PeriGen

It is time to extend AI’s use into labor & delivery departments, where the technology can help guide care teams to mitigate risks and make informed decisions.

Manufacturing 101 Manufacturing 101:
What is Metal 3-D Printing?

By Matt Sand, 3DEO

Advanced manufacturing technology in the here and now.

Featured Quote

It is clear that software engineers, designers, product managers and companies building healthcare technology have a direct impact on patient care and the lives of industry professionals. User experience should never be seen as a secondary priority. It must be part of the cultural fabric of the company.

— Christopher McCann, snap40

2019 MedTech Predictions 2019 MedTech Predictions

By MedTech Intelligence Staff

Smart technologies will continue to play a big role in advancing decision-making efforts.

Amazon Comprehend Medical Amazon’s Software Service Mines Medical Records, Aims to Improve Treatment and Lower Costs

By MedTech Intelligence Staff

Amazon Comprehend Medical uses machine learning to pull important medical information from patient records.

Sponsored Content

Accumold 5 Things Everyone
Needs to 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? – are commonly asked by engineers. This whitepaper will explore the answers to these and other pertinent questions.

3M - Learn the science of sticking to skin

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

Pacifc Bridge Medical Find Reliable Sourcing & Manufacturing Partners You Can Trust in Asia

Asia has become the chief manufacturing center for medical devices and components, but common poor supply chain practices in the Asian markets can have a serious negative impact on your business. PBM’s on-the-ground experts in Asia will assist you in finding experienced manufacturers, conducting quality audits, ensuring compliance with standards, managing the supply chain, and more.

Learn about how we can help you build long-term, reliable sourcing and manufacturing partnerships.

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

February 5-6, 2019 - EU MDR Remediation Strategy
Washington, DC

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

March 5-6, 2019 - Med Tech Import/Export
Washington, DC

March 7-8, 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