First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

Deciphering Medical Risk with High-Performance Computing

Specialized computational algorithms provide for highly efficient DNA sequence analysis.

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...

How to Protect Patients from Potential Electrical Failure

People and power don’t mix well, and this is particularly true when people are medical patients. Aside from the more usual environment of a medical facility, patients are also...

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...

Ensuring a Safe Medical Design

Until recently, developers and manufacturers of medical devices have not been required to consider security in their products. New guidance from the U.S. Food and Drug Administration (FDA) and expanded European...

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...

Chemical Characterization Can Supplement and Support Biocompatibility Testing

Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility...

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...

ISO 80369 Standards for Small Bore Connectors Move Closer to Implementation

After a 20-year effort to establish standards which would minimize the risk of medical misconnections, the pending release of the ISO 80369 series of standards has...

How to Simplify Medical Device Software Integration and Certification

Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. With a rise in mainstream...

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...

Determining Risks of Nickel in the Heart

Materials scientists at the Friedrich Schiller University of Jena, Germany, have examined implants made of nickel-titanium alloy in a long-term study and have determined that the release of nickel...

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...

Valve Selection for Disposable Devices: Beyond the Specifications

Valves are critical components of many disposable medical devices. They are responsible for controlling the movement of fluid, which could be a pharmaceutical or nutritional...

Key Considerations for Integrating Wireless Technology in Medical Devices

Wireless technology increases the effectiveness of countless every day functions. While some simply are about the convenience factor, like being able to quickly...

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...

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...

The Automation of FDA Medical Device Design Controls

Every medical device company faces the challenge of navigating through the FDA’s mandatory regulations, and companies have different needs that change as they mature. Early-stage medical...

Assessing a Patient's Risk for Sudden Cardiac Arrest

Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, accounting for an estimated 300,000 deaths each year — more than lung cancer, breast cancer, and HIV/AIDS...

Medical Device Testing: Start With a Strategy and Plan

Most medical device manufacturers must first receive approval from the U.S. Food and Drug Administration (FDA) before they can market a medical device. Device manufacturers must...