FEATURED EDITORIAL

FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained
FDA's Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program Explained

The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.

Micro-MIM Succeeds At Making Precise Micro Metal Parts

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.

How To Uncover The Hidden Value Of Culture In Supplier Selection

The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.

Taking Micromolding To the Next Level

Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production. 

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SOLUTIONS

Medical Light Sources And Components Medical Light Sources And Components

SCHOTT Lighting and Imaging delivers medical light sources to help redefine the boundaries of medical innovation, and provide deeper insights in helping medical experts see more of what is relevant to their diagnoses and therapies. 

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Rapid Tooling And Medical Device Prototyping Rapid Tooling And Medical Device Prototyping

Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Motion Control Products: Coreless Motors Motion Control Products: Coreless Motors

Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.

In Silico Simulation For Enhanced Device Performance: 3DEXPERIENCE® Platform In Silico Simulation For Enhanced Device Performance: 3DEXPERIENCE® Platform

SIMULIA’s solutions for medical device development provides a framework for engineering teams to integrate the tools they use into re-usable, deployable processes. This reduces time-consuming and error prone tasks to improve productivity and consistency, while enabling design exploration studies to find better designs and democratization to expand the user-base for simulation. Lastly, capturing these processes in the 3DEXPERIENCE® platform provides the traceability organizations need when making critical business decisions.

Low Volume Molding Low Volume Molding

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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FEATURED SUPPLIERS

KMC Systems KMC Systems

COBAS BIO Clinical Chemistry Analyzer|COBAS FARA|Clinical Diagnostic Instrumentation

MED DEVICE ONLINE CONTENT COLLECTIONS

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In the age of connectivity and precision medicine, cybersecurity has taken on critical importance in medical technology development. Software intrusions can risk patients’ health and well-being, as well as their personal data. Device designers must balance these concerns against healthcare provider and patient demand for more connectivity, more access to information, and more ease of use. In this free collection of articles, Med Device Online has collected insights from some of the cybersecurity experts among our editorial contributors.

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 EVENTS

Preparing eCTD Submissions: A Step-By-Step Guide November 19 - 19, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance November 20 - 20, 2019
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Establishing Appropriate Quality Metrics November 21 - 21, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FDA/CMS Summit December 3 - 4, 2019
Arlington, VA
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach December 5 - 5, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Delivery Partnerships (DDP) March 30, 2020 - April 1, 2020
Orlando, FL
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