MedTech Intelligence Volume 11 Issue 01

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	Volume 11 Issue No. 01

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

Scott Edwards, Maetrics Breathe Easy on CERs

By Scott Edwards, Maetrics

The first critical step in being able to feel confident about your clinical evaluation reports (CERs) is to ensure you know exactly what they entail.

Featured Articles

Edwards Lifesciences Corp. Edwards’ Sapien 3 Ultra
Valve Wins FDA Approval

By MedTech Intelligence Staff

The approval is for transcatheter aortic valve replacement in severe symptomatic aortic stenosis patients.

MedTech Intelligence Advanced CAPA Conference
Digs Deep into Challenges and Root Cause Analysis

By MedTech Intelligence Staff

This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.

Soapbox

Timothy Lozier, EtQ, Inc. Software Needs for Investigating, Reporting and Tracking Safety Incidents

By Tim Lozier, EtQ, Inc.

A look at considerations that will help prevent recurrence and minimize damage.

Featured Quote

Part of the answer to achieving better outcomes for mothers and babies lies in supporting clinicians with health IT tools, especially artificial intelligence (AI)-driven technology solutions, during labor and delivery.

— Alana McGolrick, PeriGen

Soapbox

Kurt Hagerman, Coalfire Healthcare Breaks Out in 2019

By Kurt Hagerman, Coalfire

Trends that push boundaries and shake up medical device security.

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

Advanced CAPA & Root Cause Analysis Conference - March 26-27, 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

Contact Marc Spector about MTI advertising programs.

Sponsored Resources

WuXi AppTec The Regulatory Consultant's Guide to ISO 10993-1, -17 & -18

Updates & What to Look for in Chemistry Reports

With changes to ISO 10993-1 Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval. In this webinar you will learn how to interpret ISO 10993-1 and what changes are coming with the next release of Part 17 and Part 18, best practice in developing test plans and analyzing chemistry reports and the components of a complete biological evaluation.

Upcoming Events & Webinars

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

March 26-27, 2019 - Advanced CAPA & Root Cause Analysis
Washington, DC

April 15-26, 2019 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC

April 16-1733, 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 4-5, 2019, 2019 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC