Medical Device Regulations & Compliance

INDUSTRY PERSPECTIVES

The Regulatory Affairs Function Is Evolving. Are You Evolving With It?

The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.

The ABCs Of PCCPs (Predetermined Change Control Plans)

The FDA’s Predetermined Change Control Plans (PCCPs) tool aims to ease the regulatory burden of updating AI/ML algorithms. Software-enabled medical device companies that master this tool will be able to more rapidly improve their device products.

Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices

The FDA categorizes AI-enabled medical devices as types of SiMD or SaMD innovations. This patent lawyer provides practical recommendations and considerations.

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.

WHITE PAPERS & CASE STUDIES

Solving The Silicone Challenge In Pre-Fillable Syringes

Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

Performance Test According To Chapter <41> Of The USP

This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.

Eccentric Loading Test (Eccentricity) With External Test Weights

In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.

One-Point Calibration With External Test Weights

This operating procedure describes how to perform a one-point calibration with external test weights, which is one of the recommended tests to ensure laboratory balances are working correctly.

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