Newsletter | October 8, 2024

10.08.24 -- Your 510(k) Hasn't Sailed Through. Now What?

FEATURED EDITORIAL

Your 510(k) Hasn't Sailed Through. Now What?

Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA. What can you do when the agency rejects your 510(k) or requests more information? How can a Q-Sub help? This article shares practical recommendations.

INDUSTRY INSIGHTS

How DFM Promotes Scalability, Repeatability, And Profitability

DFM discussion must be concise and backed by both historical data and up-to-the-minute insights, e.g., discovered through prototyping, test runs, etc.

RFID For Medical Devices

RFID technology offers various benefits for medical devices, including authentication, device tracking, sterilization, and supply chain management. It improves efficiency, reduces errors, and ensures compliance with industry standards.

Pushing Technology Limits Helps Startup Launch Novel Balloon Catheter

Nordson MEDICAL helped a startup develop a balloon catheter for atrial fibrillation, leading to its acquisition by a major medical technology company. They offer a range of components and tools, and specialize in medical device design and manufacturing.

Xover Valve Flow Cytometry

The Xover Valve excels wherever low crossover, low shear, and low internal volume switching is required. Learn more about this valve and its applications and benefits in this overview.

Planning For Extractables And Leachables Studies To Meet Timelines

Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

ARTICLES YOU MAY HAVE MISSED

Nuances Of The Growing U.S. Market For Advanced Wound Dressings

Pharma's Data Secret That Medical Device Companies Should Adopt

How Chile Is Shaping Medical Device Clinical Trials In Latin America

Ensuring Privacy & Security In Smart Medical Devices

Breast Reconstruction In The U.S.: Procedure Preferences & Market Trends

RESOURCES

Injection Molding Vs. 3D Printing

The Aqueous Cleaning Handbook

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