FEATURED EDITORIAL

What Happens To ISO 13485 When Annex L Is Adopted?
What Happens To ISO 13485 When Annex L Is Adopted?

Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.

  • 4 (More) Critical Considerations For Drug Delivery Device Development
    4 (More) Critical Considerations For Drug Delivery Device Development

    The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

  • MDSAP — History and Advantages
    MDSAP — History and Advantages

    The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.

  • What Your Organizational Design Says About Your Commitment To Data Integrity
    What Your Organizational Design Says About Your Commitment To Data Integrity

    Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

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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

FLIR Research Studio: Designed To Work The Way You Do FLIR Research Studio: Designed To Work The Way You Do

The new FLIR Research Studio is a powerful, yet simple to use software for analyzing how thermal imagery changes over time. Designed to work the way you work, the software makes thermal analysis faster, more convenient, and enables better teamwork. Whether a Windows, MacOS or Linux user, Research Studio provides customers with an easy way to quickly and efficiently display, record, and analyze accurate thermal data on their machine in any one of the available 22 languages. 

Label and Artwork Management Software: PRISYM 360 Label and Artwork Management Software: PRISYM 360

PRISYM 360 is the ONLY labeling solution dedicated to Medical Device and Life Sciences. PRISYM 360 provides organizations with complete label integrity to meet the strictest compliance requirements for FDA and EU regulations.

By focusing on the data, rather than the label/artwork, PRISYM 360 provides a revolutionary 360° outlook of your master data assets and gives the ability to control and optimize them to create a fully integrated approach across the full label lifecycle.

Due to the information being data driven, it lets you to find out where content sits quickly and easily, allowing you to deal with mass change. This feature has annually saved customers multi- million dollars on global label change, while reducing the risk of the label carrying old data or using the wrong version.

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.

Glass Micro Bonding Benefits And Applications Glass Micro Bonding Benefits And Applications

SCHOTT Electronic Packaging and Primoceler Oy have joined forces to expand current hermetic packaging portfolios with pioneering glass micro bonding technology. This process enables the manufacture of vacuum-tight, ultra-miniature electronic and optical devices with superior reliability. This bonding method is based on laser technology and can be completed without any heat or added materials.

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.

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.

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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.

SCHOTT North America, Inc. - Lighting and Imaging SCHOTT North America, Inc. - Lighting and Imaging

SCHOTT Lighting and Imaging specializes in design and manufacture of fiber optic, LED, optical and hybrid product solutions for use in medical, dental, scientific, industrial, defense, aviation and automotive applications. In the medical field, SCHOTT specializes in custom solutions for OEM manufacturers such as leached fiber optic image bundles and light guides for endoscopy applications, fused fiber optic tapers and faceplates for x-ray applications and flexible wound fiber bundles for MRI applications.

MED DEVICE ONLINE CONTENT COLLECTIONS

MDO_RegulatoryEbook_300x200

 

What is our readers’ greatest shared concern? Demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Learn more in this free collection of articles highlighting how regulatory confusion can be time-consuming, costly, and damaging to your brand.

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 EVENTS

The MedTech Conference September 23 - 25, 2019
Boston, MA
Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers September 24 - 24, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Sterility Failure Investigations – A Step-by-Step Process for Success September 30 - 30, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in! October 1 - 1, 2019
1pm-2:00pm EDT, Online Training
Duration:  60-Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Research Project Management - 7 Breakthrough Behaviors For Success October 3 - 3, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
PODD: Partnership Opportunities in Drug Delivery October 7 - 8, 2019
Boston, MA
Effective Batch Record Review – Getting It Right The First Time October 9 - 9, 2019
1pm-2:30pm EDT, Online Training
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Aseptic Process Validation: Top-Tips for Compliance and Success October 10 - 10, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Writing Effective 483 and Warning Letter Responses October 23 - 23, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
MedTech Commercial Leaders Forum 2019 November 5 - 7, 2019
Brussels
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