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

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MedTech Intelligence

Volume 10 Issue No. 45

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


Three Hospital Trends Impacting Medtech ManufacturersThree Hospital Trends Impacting Medtech Manufacturers

By Patrick Vega, Vega Healthcare

How manufacturers can better understand their customers in a rapidly changing provider environment.

Featured Articles


Bryan Brosseau, Brosseau Consulting, LLCSupplier Quality Considerations For Quality and Regulatory Service Providers

By Bryan Brosseau,
Brosseau Consulting, LLC

When outsourcing these key functions, asking the right questions will help minimize the risk.


EU MDR Compliance CostLast Chance:
What’s the Cost of Compliance
with EU MDR?

By MedTech Intelligence Staff

This is your final chance to take the survey before results are revealed next week.

Why Paper-Based Systems No Longer Make the Cut Why Paper-Based Systems No Longer Make the Cut

By Alex Condon, Galen Data;
Chris Byers, Formstack; and
David DeRam, Greenlight Guru

Here’s what these three CEOs think about why the transition to digital is more important than ever.

Sponsored Content

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[VIDEO] Learn what skin means to Jacquie & Milena

Designing devices for skin requires a skin-first approach. Watch the video and download this complimentary report to find out why.


More Articles »


Sponsored Resources

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TransPerfectThe Cure for the MDR/IVDR Labeling & Content Headache

Join TransPerfect at MTI’s EU MDR Conference to Learn More

The Diagnosis: MDR/IVDR will generate more content, updates, translation, and publishing with increased regulatory scrutiny; impossible to support with traditional document-based systems (InDesign, Word, Frame). The Treatment: Structured content (XML/CCMS) + translation process automation (with AI-Assist™) is a modular solution for a division or entire enterprise. New Rapid Prototyping Program provides measurable proof of concept.


MedTech IntlligenceMedical Device Process Validation

A Virtual Conference | January 29 - 30, 2019

Deficiencies in process validation and other aspects of production and process control earn more FDA enforcement actions than any other quality function except CAPA. This two-day workshop addresses key issues in process validation, including risk-based determination of processes to be validated, FDA and 13485:2016 requirements, key process validation elements and best practices, statistical and other tools, maintaining the validated state, and documentation.

Attend virtually from your location!

Upcoming Events & Webinars

Nov. 2018November 27-28, 2018 - EU MDR Implementation Strategies Workshop
Washington, DC

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

JanuaryJanuary 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

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