Newsletter | November 5, 2024

11.05.24 -- A New Approach To ISO 14971 For Better Medical Device Risk Analysis

FEATURED EDITORIAL

A New Approach To ISO 14971 For Better Medical Device Risk Analysis

This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

INDUSTRY INSIGHTS

How Sensor-Enabled Catheters Are Driving Healthcare Innovations

Sensor technologies embedded in catheters are enhancing surgical precision and real-time monitoring capabilities. Explore how these innovations are reshaping medical procedures and patient outcomes.

10 Ways To Align Your Medical Device With Industry Best Practices

Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

Verticle Integration Drives Success In Tolerance Attainment For Micro Molding

Micro molding demands tight tolerances for precise parts in medical, electronics, and micro-systems. Vertical integration offers control for high-quality micro-molded components.

15 Reasons To Implement RFID In Medical Devices

Discover the importance of integrating RFID technology into medical devices for improved tracking, supply chain management, and patient safety — enhancing security, traceability, and compatibility.

Medical Grade Capacitors For Medical Implantable Devices

The MD series medical-grade capacitors ensure high reliability for implantable devices, offering screened and unscreened options to streamline prototyping and production for medical device designers.

ARTICLES YOU MAY HAVE MISSED

Computer Systems Validation Pitfalls, Part 1: Methodology Violations

The ABCs Of PCCPs (Predetermined Change Control Plans)

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

RESOURCES

The Advantages of Shotscope

Aidaptus Manufacturing

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