Risk Management for Cybersecure Networked Medical Devices

For developers and manufacturers of networked medical devices, IT security is increasingly becoming a challenge. While the number of cyber threats is growing significantly,...

Medical Device Usability Requirements: Changes to IEC 62366

The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.

Strategies for Low-Risk Sourcing of Components in a Constrained Market

The medical device industry often looks to independent distributors to address chronic shortages in the availability of electronic components. Direct sourcing of...

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...

Core Competencies: Staying Competitive in the Medical Device Industry

Staying competitive calls for medical equipment OEMs to constantly keep pace with the speed of innovation. Better medical treatment and care can be achieved with fast,...

Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

Advances in Hydrophilic and Hydrophobic Coatings for Medical Devices

The medical device industry, driven by innovation and new technologies, has become one of the biggest markets in healthcare. The explosion in sophistication and application...

Addressing Cleaning Challenges for Medical Electronics

The market for medical electronics is huge and growing. The astounding capabilities of digital technology and broadband connectivity are “a perfect storm,” enabling doctors...

EMC Requirements: Pending Changes for the Fourth Edition of IEC 60601-1-2

Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC...

Designing Cybersecurity into Connected Medical Devices

Cyber threats to health delivery organizations (HDOs) and the medical device industry as a whole have hit a new level of maturity in the last year. A decade ago, the attack scene was...

Understanding Proper Cleaning Procedures for Medical Device PCBs

Printed circuit boards (PCBs) are critical components in many medical devices. Prior to shipment to the OEM, PCBs must undergo a thorough cleaning process to remove excess...

Design Validation and Regulatory Requirements

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Solving the Compliance Puzzle for Medical Startup Companies: The Entrepreneur’s Basic Guide to Understanding Product Regulations & Testing

Often, the last thing first-time and even serial entrepreneurs think about is how the result of...

New Medical Device EMC Requirements

Implementation of IEC 60601-1-2, 4th edition is on the horizon. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for...

Designing for Regulatory Approval: What is Important to Regulators in the Approval Process?

Giving attention to regulatory considerations at the earliest stages of product design and development can create a smoother and more successful...

Critical Steps for Developing a Successful Medical Device Interconnect Cable

It seems the biggest ideas get the most attention, and nothing could be more true than when launching a new medical technology, and/or devices. The development time...

Today’s Changing Healthcare Demands Have Big Impact on Power Supply Design Considerations

It is clear that the medical electronics industry has entered an era of dramatic transitions that touch virtually every aspect of the business from...

Standard Security Framework for Medical Device Technologies: A Work in Progress

Collaboration among healthcare technology stakeholders—from device manufacturers and healthcare delivery organizations to healthcare security intelligence...

Design Criteria of Power Supplies for Use in Medical Devices

The third edition of IEC 60601-1 has been in effect since June 2012. It replaces the previous version as a basic standard for medical electrical equipment and describes the general...

Best-in-Class Technologies for High Performance, Compliant Mobile Medical Devices

Portable and wearable healthcare devices represent growing, high volume markets for the medtech industry. Patient monitors are evolving from stationary...

Safety and Human Factors Engineering in Medical Device Design

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety...

Managing Risk in Medical Connectors

Every day, medical device manufacturers are getting better and better at managing risk. They know they have to. Changes have been introduced into international regulatory schemes that impact device design...

Endotoxin Testing: FDA Update Prompts Time for Review

The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of...

Quality Management: Key To Medical Electronics Assembly and Manufacturing

No other industry in the US is under more pressure than medical electronics, and those pressures continue mounting each year for greater innovation and products that...

Risk Assessment for Power Supplies to Comply with IEC 60601-1 3rd Edition

For medical device OEMs seeking compliance to the 3rd Edition of IEC 60601-1 for their power supplies, what is quite clear by now are the regional dates for...

Design for Manufacturing: Concept to Reality

Design for Manufacturability (DFM) is a well-established practice, essential in realizing the transformation of new product concepts into mass-produced medical devices. And yet, all too often...

Cloud-Based Product Lifecycle Management for the Medical Industry

The medical industry stands to benefit immensely from cloud-based product lifecycle management (PLM). The mountains of information that medical companies must manage when...