FEATURED EDITORIAL

The Digital Health Tsunami Is Here. How Is FDA Gearing Up?
The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

The FDA’s Software Precertification Pilot Program moves away from the agency’s long-held stance that it does not “approve companies,” exploring new thinking on how to regulate by reputation and continuous improvement loops, rather than reviewing each and every low-risk product. Might there be a way to replicate this type of thinking for complex products?

  • MDTX Was A Cure For The “Regulatory Blues”
    MDTX Was A Cure For The “Regulatory Blues”

    Last week’s MDTX event was a thought leaders' forum for medical device innovators who design, develop, or commercialize devices. There were interesting conversations with speakers and leading-edge knowledge from experts about everything from concept to commercialization, and regulations to reimbursement. My own presentation was on recently-released FDA guidance documents and how these new expectations might influence your next product development effort.

  • Express And Implied Preemption For Premarket-Approved Medical Devices:  A Dual Shield Against Tort Claims
    Express And Implied Preemption For Premarket-Approved Medical Devices: A Dual Shield Against Tort Claims

    In the past 10 years, manufacturers have used express and implied preemption to shield themselves from personal injury tort lawsuits involving PMA medical devices, but plaintiffs’ attorneys have sought to poke holes in these shields, occasionally establishing certain limited exceptions to these preemption defenses.

  • Buying More Time For Stroke Victims
    Buying More Time For Stroke Victims

    Fresh regulatory updates and a new generation of medical devices are expanding caregivers’ options for the early management of patients with acute ischemic stroke.

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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 Device Supply Chain Management (Metals, Electronics) Medical Device Supply Chain Management (Metals, Electronics)

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

Pressure Relief Valves (For Plastic) Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

FluoroPEELZ™ Peelable Heat Shrink FluoroPEELZ™ Peelable Heat Shrink

Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.

In Vitro Diagnostics

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

More Products & Services

FEATURED SUPPLIERS

Ophir Photonics Ophir Photonics

Ophir Photonics, a Newport Corporation, began making laser power meters, energy meters, and beam profilers in 1979, and we’ve never looked back. We have headquarters in the United States, Israel, Japan, and Germany, as well as distributors in over 50 countries worldwide.

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

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 EVENTS

Instructional Design for GMP Training – Improve Effectiveness and Measurability April 24, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works April 25 - 25, 2018
2pm-3:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions May 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $199 - Includes Bonus Handouts!
Effective Batch Record Review - Getting It Right The First Time May 7 - 7, 2018
RECORDING, Online Training)
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements May 8 - 8, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Guidance for Industry “Process Validation: General Principles & Practices” – Whatever Happened to IQ, OQ, PQ? May 16 - 16, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Core Competencies of a World-Class Medical Affairs Team May 17 - 17, 2018
1pm-2:00pm EDT, Online Training)
Price:  $199 - Includes Bonus Handouts!
The EU General Data Protection Regulation (GDPR): What US Companies Need To Know To Comply May 22 - 22, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Onboarding Employees In A GMP Environment: Best Practices For Foundational Employee Success May 24 - 24, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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