Newsletter | October 12, 2023

10.12.23 -- A Brief Guide To ISO 13485's Design Controls In Medical Device Development

FEATURED EDITORIAL

A Brief Guide To ISO 13485’s Design Controls In Medical Device Development

Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.

INDUSTRY INSIGHTS

Proactive Total Quality

Learn how Proactive Total Quality provides a data-driven framework for innovation for medical device companies to thrive and deliver life-saving and life-enhancing products, as they always have.

CM Partnering For Adaptable, Accelerated Market Acceptance

The need for manufacturing support that offers adaptable, scalable solutions has become more crucial than ever for the diagnostic space.

Choosing The Right Primary Container And Troubleshooting Issues

Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development — and quickly uncover causes of failures.

Four OEM Benefits For RFID-Enabled Medical Devices

RFID technology has changed the ways in which OEMs fabricate, distribute and market modern medical devices and provides medical facilities and their patients with real and measurable benefits.

Nitinol Wire Forming And Manipulation For Custom Components

With its shape memory properties, nitinol wire is a highly suitable material for medical applications. Explore the process of forming and manipulating nitinol wire to produce personalized components.

Elements Of Design: Dealing With Suspect Parts

Learn about an injection molding solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to reject parts that do not make the cut in the molding process.

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.

ARTICLES YOU MAY HAVE MISSED

Biosensing Technology: Where Is The Field Headed?

Global Market Trends For Drug-Device Combination Products

FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?

The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic

Surgical Camera Systems: Are 3D Systems A Niche Product Or the New Standard?

RESOURCES

The Aqueous Cleaning Handbook

Micro 3D Printing Handbook

Assembly Services

LT Series Disc Pump

Connect With Med Device Online: