Crescent Industries - Scientific Injection Molding Process & Benefits White Paper

MedTech Intelligence

Volume 11 Issue No. 10



Charlie Kim, SoomNow You’re Speaking My Language:
Modernizing Instructions for Use to Comply with MDR

By Charlie Kim, Soom

The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.


EU MDR Workshop Series -

Featured Articles

Maria Fontanazza, Editor-in-ChiefCDRH Warns of Potential Device Shortage with Shutdown of Sterigenics Facility in Illinois

By Maria Fontanazza, Editor-in-Chief

According to the FDA, more than 90% of products sterilized at the facility are medical devices.

FDA Commissioner Scott Gottlieb, M.D.Report: FDA Commissioner Scott Gottlieb Resigning

By MedTech Intelligence Staff

The resignation will be effective in about a month, according to reports.

Trends in MedDesign

Jacob Krive, Ph.D., University of Illinois, College of Applied Health SciencesIs the Healthcare Industry Ready to Embrace a Consumer Wearable
Device Revolution?

By Jacob Krive, Ph.D, University of Illinois, College of Applied Health Sciences

The success of these technologies also relies on simplification to target certain patient populations, ensuring secure data transmission, and that operational models are built to make effective use of the data.

Brian Ochs, 3M Medical Materials and TechnologiesFive 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.

Sponsored Content

SiemensIntelligent Design Control for Medical Devices

Join us to learn about the Siemens Digital Enterprise Framework for Intelligent Design Control: an integrated, systematic, logical system for building & maintaining product design control for medical devices, integrating requirements & risk management, test planning & execution, and design output management, including Design History Files and Device Master Records

Register Now to our Live Webinar

Advanced CAPA & Root Cause Analysis Conference - March 26-27, 2019 - A Virtual Event

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

Medical Device Recalls Conference - June 24 - 25, 2019 - Washington, DC

Global Regulatory Strategy - October 22-23, 2019 - Washington, DC

Contact Marc Spector about MTI advertising programs.

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

3MWhitepaper - The impact of regulatory requirements on bringing medical devices to market.

There are many steps involved in the process of bringing a device to market, especially examining the regulatory environment in which medical device customers operate. Depending on your device, its indications or the presence of drug or biologic components, submissions to the U.S. FDA, EU Notified Bodies or Competent Authorities, and other regulatory bodies might be considered, but if you're using a component as a layer between other components of your medical device, or if you're using a component to adhere a device to skin, more may be expected from you by the FDA or other regulatory agency reviewers. When adhering a device to skin special attention should be given to the final, finished device composition and biocompatibility, inclusive of all component(s).

Access this white paper here.

Upcoming Events & Webinars

March 2019March 26-27, 2019 - Advanced CAPA & Root Cause Analysis
A Virtual Event

April 15-16, 2019 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC

April 16-17, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

May 21-22, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
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

June 24-25, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

OctoberOctober 22-23, 2019 - Global Regulatory Strategy
Washington, DC

OctoberOctober 23-24, 2019 - MedTech M&A: Regulatory & Quality Due Diligence
Washington, DC

NovemberNovember 13-14, 2019 - India - the MedTech Market: Strategic Planning & Practical Considerations
Washington, DC

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