Establishing Proper Validation of Extruded Silicone Tubing

Bring your project from the process development phase of manufacturing to a fully validated one.

New Requirements for Medical Device Cleaning Validations: An Overview of ST98

As medical devices become more advanced and innovative, so do the regulations that surround them.

Creating Robust Reprocessing Instructions for Reusable Device IFUs

Developing IFUs for reusable devices presents a unique challenge that requires focused attention to ensure patient safety: the reprocessing method.

Mastering the UKCA Compliance Challenge

Deadlines are approaching for compliance.

Design Strategies for Converting Rotary Motion into Linear Motion

Medical pipettes, syringes, and mesotherapy devices often move loads linearly instead of rotationally.

Impact Modified Acrylic Copolymers: Understanding Chemical Resistance

An objective screening matrix to enable medical device manufacturers in identifying the appropriate material for device assemblies.

New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020

Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.

Determining When to Outsource Your Medical Device Testing

Weighing your testing options is imperative to submission success.

Medical Device Innovation: Three Keys to Success in the Face of COVID-19

Having a strong business plan can provide a resilient foundation for successful medical device innovation.

LSR Technology: A New Dimension in Design of Medical Devices

Learn how liquid silicone rubber (LSR) is playing a major role in the fabrication of new medical devices.

EU MDR Economic Operators: Sharing Compliance Duties across the Supply Chain

A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."

Your MDR Strategy: Start with a Gap Analysis

How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.

Class I Manufacturers: 8 Steps to Tackle EU MDR Compliance

Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

Reducing Risk with Geometric Transition Extrusion

In an effort to design smaller, more intricate and complicated medical devices without running afoul of increasingly stringent national and international regulations, many designers are...

A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Guide to Package Integrity & Validation Testing under ISO 11607 and MDR

Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful...

Why Cloud QMS Better Supports Regulatory Compliance

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

Electrical Connectors: Design Considerations for Medical Devices

The myriad of devices used in surgical, interventional, imaging, diagnostic and therapeutic, sensors, and single-use medical applications use some form of transmission medium...

Integrating Vision and Force Measurement into Medical Quality Control

Vital for ensuring compliance to federal regulations, dimensional metrology systems facilitate critical measurement of medical parts, and force testing systems are used to...

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...

Guide to FDA Requirements and Importance of Medical Device Calibration

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....

3D Printing Fuels the Rise of Point-of-Care Medical Manufacturing

More than 95 percent of point-of-care (POC) professionals expect to see an expansion of POC manufacturing enabled by additive manufacturing, commonly called 3D printing....

Software: Improving Risk Management in Medical Device Manufacturing

In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for...

Design Controls: Addressing Changes in ISO 13485

When ISO 9001 was produced by the International Standards Organization, it put forth the general quality standard that organizations could adopt to ensure that the organization is focused on...

Keeping Your Eye On UDI

As medical technology accelerates at an almost incomprehensible pace, regulations and requirements increase correspondingly. With rapid innovation and the desire to speed time to market comes more rigorous...

Project Management: Four Trends to Follow in 2017

We are living through an era of profound change. Technology is affecting this change in ways unthinkable only a decade ago and none more so than in the medical device industry. A tour of life...

From the Editor — A Cure for the U.S. Medical Innovation Ecosystem

As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of...