MedTech Import/Export: Regulations, Procedures, Best Practices - October 24, 2018 - Washington, DC

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MedTech Intelligence

Volume 10 Issue No. 37

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

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Big Butts, Take Three!

By Dr. Christopher Joseph Devine,
Devine Guidance International

It is our responsibility to educate family and friends about the dangers associated with the practicing of backroom medicine.

Ames Gross, Pacific Bridge MedicalExpanding Hospital Markets in Asia Provides Opportunities for MedTech Manufacturers:
The Hospital Markets in India and Southeast Asia (Part II)

By Ames Gross, Pacific Bridge Medical

A review of the status and prospects of key markets in India, Thailand, Indonesia and Vietnam.

Sharmistha Sarkar, Allied Market ResearchOperating Room Integration System Market to Grow Alongside Rising Demand for Minimally Invasive Surgeries and Need for Good Quality Care

By Sharmistha Sarkar, Allied Market Research

The market is projected to hit nearly $4.2 billion by 2025.

 
 

FDAFDA Issues Draft Guidance on Considerations of Uncertainty in Making Benefit-Risk Determinations for Premarket Decisions

By MedTech Intelligence Staff

The agency is aiming to provide more transparency and consistency in this area.

FY 2019 Medical Device User Fees Increase 4%FY 2019 Medical Device User Fees Increase 4%

By MedTech Intelligence Staff

The increase is significantly less than FY 2018, which saw user fees go up 33%.

 
Sponsored Content

Crescent IndustriesHow to Choose the Right Material for Your Medical Device

The best resin or combination of resins for a particular product depends a lot on the device’s requirements, correct material selection early is critical because it’s often costly to change resins after an injection mold has been fabricated. By asking these three questions at the beginning of the design process can guide OEMs towards more optimal material choices for their next medical device product.

  • What Unmet Need is this Device Satisfying?
  • What Performance Demands Does the Design Place on the Material?
  • What is the Target Cost per Part?

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More Articles »

MedTech M&A: Regulatory & Quality Due Diligence

Upcoming Events & Webinars

Oct. 2018October 22-23, 2018 - Med Tech M&A: Regulatory & Quality Due Diligence
Washington, DC

Oct. 2018October 24, 2018 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC

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

Nov. 2018November 29-30, 2018 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

Q1 2019Q1 2019 - Digital Health Technologies Conference
Silicon Valley, CA

Q1 2019Q1 2019 - Medical Cybersecurity - Remediation of Legacy Medical Devices
Silicon Valley, CA

Q1 2019Q1 2019 - MedTech Innovation Mergers & Acquisitions Workshop
Silicon Valley, CA

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