LEAD STORIES

China Food And Drug Administration Updates Clinical And Registration Requirements

The China Food and Drug Administration (CFDA) last month released revisions (in Chinese) to administrative measures that, on Oct. 1, will affect the way medical devices are registered in the country.

INDUSTRY PERSPECTIVES

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2

    In Part 1 of this article, we looked at five mistakes medical device companies make during the quality management review process. In this installment, we turn our attention to measurement, analysis, and improvement activities — where several problems can occur and what you can do to prevent them. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

  • Is Your Boring Regulatory Strategy Costing You Business?
    Is Your Boring Regulatory Strategy Costing You Business?

    When people in the medical device world use the phrase “regulatory strategy,” they usually mean the path they will take to get their product onto the market. And when they say “competitive regulatory strategy,” they are usually referring to the way their competitor(s) got their products onto the market.

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1

    Establishing and maintaining an airtight quality system is a prerequisite for survival in the medical device and diagnostics industry. Problems can arise in many areas of a quality system, but one area where manufacturers struggle is in management reviews. This article identifies some of the common snares manufacturers fall prey to when conducting these reviews, and shares strategies to help you avoid those mistakes in your organization.

More Guest Columns

ARTICLES

  • Robotic Biopsy System Drives The Point Home
    Robotic Biopsy System Drives The Point Home

    Why, with CT scanners routinely achieving submillimeter resolutions, are manual needle biopsies performed with only centimeters of accuracy? To solve that issue, a team from MIT built a robotic biopsy system with unprecendented efficiency and accuracy, powered by compact, high-torque DC servomotors from MICROMO.

Biocompatibility of Anesthesia/Respiratory Products

This biocompatibility technical whitepaper is a reference guide for navigating aspects of the various biocompatibility standards for respiratory devices. It is intended to aid design engineers in understanding the complexity of biocompatibility standards as applied to anesthesia workstations, ventilators, and oxygen concentrators.

Considering Human Factors And Training In Medical Device Design

The patient has become the end user when it comes to many types of medical technology, and that trend is likely to continue with the rise of mobile health (mHealth), remote patient monitoring, and other healthcare industry drivers. As a result, the human factor is becoming increasingly important in the design of next-generation medical devices and diagnostics. 

Introduction To Injection Molding Part Design For Dummies

This article provides insight into the injection molding process that makes it possible for you to get plastic parts made in as little as one day. It provides tips on how to design your parts to make them better and easier to manufacture. It also discusses design options that allow even complex parts to be made quickly. Finally, the article provides an overview of the materials available and demonstrates how you can make your parts look great without spending too much or waiting too long.

Safety In Medical Electrical Equipment Starts With The Power Input

Electrical equipment used in medical technology must not place patients or medical staff in danger. This, in turn, requires that designing safe equipment starts at the point where the power is supplied. Power connectors and power entry modules with or without a power-line filter must fulfill the requirements of the base standard for medical electrical equipment, IEC/UL 60601-1.

More Articles

FROM THE EDITOR

  • 7 Unconventional Ways To Fund A Medtech Startup
    7 Unconventional Ways To Fund A Medtech Startup

    Bringing innovative new medical technology to market today is as challenging, complex, and competitive an endeavor as it’s ever been for entrepreneurs. Making matters worse, venture capital — the fuel that fledgling companies once depended on to drive product development — has dwindled in recent years. Hear what industry experts from Cleveland Clinic, UnitedHealthcare, and other organizations have to say about nontraditional sources of funding that just might fit the bill for your medtech startup.

  • Cutting Through The Remote Patient Monitoring Hype
    Cutting Through The Remote Patient Monitoring Hype

    There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

  • Reverse Engineering A Human Heart Valve
    Reverse Engineering A Human Heart Valve

    The man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.

More From The Editor

PRODUCT SHOWCASE

Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

Entry-Level Infrared Cameras For Research And Science Applications

Entry-Level Infrared Cameras For Research And Science Applications

These infrared cameras for research and science applications offer image quality, ease of use, and accurate temperature measurement, all with a low cost. They’re available in handheld and fixed mount configurations, and feature thermal sensitivity up to 50 mK, temperature measurement up to 2,000° C, flexible optics for close-up and distance imaging, and more. Engineers that work in general medical and bioresearch applications, as well as researches involved with universities, power conversion, the electronics industry, and solar cell development can benefit from the use of FLIR’s entry-level Infrared Cameras. This line starts at under $10,000.

Multispectral Photodiodes: PixelSensor

Multispectral Photodiodes: PixelSensor

Multispectral photodiodes by PIXELTEQ benefit from a micro-patterned optical filter technology that shrinks spectral sensors enough to pack up to eight into a 9mm square footprint. They’re ideal for applications in color meters and monitors, portable optical sensors, biomedical instrumentation, industrial sorting and sensing, and in OEM multispectral devices.

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

These high speed, low light imaging CCD cameras come in monochrome, color mosaic, and slider configurations. Each model features high sensitivity and fast frame rates, which helps greatly in preserving live cells and fading specimens for imaging and fluorescence applications.

Medical Device Prototyping & Design Services

Medical Device Prototyping & Design Services

Carclo’s product designers and engineers have multiple years of experience with medical device prototyping and design. We take a partner approach to your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

More Featured Products
Newsletter Signup
Get the latest medical device industry news, insights, and analysis delivered to your inbox.

LATEST HEADLINES

More News

UPCOMING TRAINING COURSES

Medical Device Complaint Handling and MDR Reporting

September 3, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

October 3, 2014
1pm-2:30pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Skyworks Solutions, Inc.

Skyworks Solutions, Inc.

Skyworks is the industry’s leading wireless semiconductor company focused on RF and complete semiconductor systems for mobile communications applications...