Newsletter | October 24, 2024

10.24.24 -- The ABCs Of PCCPs (Predetermined Change Control Plans)

FEATURED EDITORIAL

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.

INDUSTRY INSIGHTS

EU GMP-Annex 1: Changes, Challenges, And Ready-To-Use Sterile Packaging

Leveraging a pre-sterilized containment solution that meets the requirements of Annex 1 and outsources non-core activities can help prevent contamination and reduce the effort and liability of the CCS.

Vascular Access And Sensor-Enabled Catheters FAQ

As we add sensors to more and more devices, procedure success, safety, and patient comfort all will benefit from smaller, faster, and more accurate sensors.

Elements Of Design: Dealing With Suspect Parts

Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Learn about a solution that utilize automation to automatically reject parts that do not make the cut in the molding process.

Selecting An Aqueous Cleaning Detergent

Explore aqueous detergent selection criteria as it fits into three broad categories: function and efficacy, health and safety, and environmental.

Medical Device & OEM Consumables

Powering the trusted identities of the world's people, places & things with embeddable and custom design RFID smart components.

ARTICLES YOU MAY HAVE MISSED

Sterility Assurance: The Fundamentals

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

A Look Inside The Growing U.S. Market Landscape For Surgical Navigation & Robotics

Improving Medical Device Testing With Robotic Automation

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

RESOURCES

The Latest Innovation In Sample Switching Technology

Brochure: OmniTech HCT ABS For Molded Colored Parts

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