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MedTech Intelligence

Volume 10 Issue No. 32

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

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International What, No Risk Analysis?

By Dr. Christopher Joseph Devine,
Devine Guidance International

Procedures for design validation must address risk analysis where appropriate.

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%.

Pratik Kirve, Allied AnalyticsResearch Activities for Next Generation Sequencing Accelerate, New Studies
Outline Efficacy on Treating Fatal Conditions

By Pratik Kirve, Allied Analytics

Research and development activities to find potential treatments using next generation sequencing for various fatal conditions including melanoma, epilepsy, antibody deficiency, and other diseases have gained traction. In April, FDA finalized two guidance documents to speed up development of NGS-based tests.

Ameing for Asia

Ames Gross, Pacific Bridge MedicalCutting-Edge Atrial Fibrillation Devices Revitalize
Japanese Market

By Ames Gross, Pacific Bridge Medical

MRI-compatible pacemakers are among the technologies gaining traction.

 
 

Peter Rose, MaetricsNew MDR:
One Year into the Transition Period

By Peter Rose, Maetrics

After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.

Shilpa Gampa, FreyrNew EU MDR Regulations
and Revamp of the Medical Device Directive

By Shilpa Gampa, Freyr

An overview of the key impact points and challenges of European Union Medical Device Regulation.

 

More Articles »

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

Sponsored Resources
 

ULMedical Device Compliance for the UL 2900-2-1 Standard

Hospitals and other healthcare institutions work with regulators to achieve the security assurance and/or certifications they desire. Read how UL’s accreditation programs, healthcare IT experience, and testing services can assist regulators with UL 2900-2-1 standard compliance, risk mitigation and more.

Upcoming Events & Webinars

Sept. 2018September 17-18, 2018 - Medical Device Process Validation Virtual Conference
Washington, DC

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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