Crescent Industries

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MedTech Intelligence

Volume 11 Issue No. 02

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

Sean Otto, Ph.D., CyientIntegrating Data Science into
Medical Device Development

By Sean Otto, Ph.D., Cyient

Successful integration requires a rethinking around the role of data science in product design and lifecycle management.


EU MDR Workshop Series -

Featured Articles

Ames Gross, Pacific Bridge MedicalMedical Device Market for Prostate Cancer Treatment in Asia Poised for Major Growth

By Ames Gross, Pacific Bridge Medical

A rapidly aging population, along with economic growth and rising industrialization, is driving a big increase of the disease.

MedTech IntelligenceHow the Government Shutdown Affects Medical Devices

By MedTech Intelligence Staff

Mission critical activities, such as device recalls and surveillance related to product safety concerns will continue.


Kurt Hagerman, CoalfireMisconceptions 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.


More Articles »

Resource Centers

Resource Centers are single topic focused micro-sites within that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Cybersecurity Conference - June 4 - 5, 2019 - Boston, MA

Sponsored Resources

TransPerfectHow will new EU Medical Device Regulation disrupt and transform the industry?

One rough estimate is that the total cost of compliance, industry-wide, will be between 3.5% and 5% of revenue" – in other words: $20 billion. TransPerfect has answers for manufactures combining patented language services with validated automation technologies for solutions designed to address the complex challenges of MDR/IVDR compliance.

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MedTech Import/Export Workshop - April 15 - 16, 2019 - Washington, DC

Upcoming Events & Webinars

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

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

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

March 2019March 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 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 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Boston, MA

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