FEATURED EDITORIAL

The Least Burdensome Provisions: Concept And Principles Guidance Summary And Analysis
The Least Burdensome Provisions: Concept And Principles Guidance Summary And Analysis

While the new version of The Least Burdensome Provisions guidance does not institute sweeping reforms, it does offer new methods for medical device manufacturers to expedite the premarket review process for product approvals, as well as clarifies how both the FDA and industry can implement the least burdensome principles in practice.

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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

Engineering And Design Services Engineering And Design Services

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

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.

Detergent 8: Low-Foaming Ion-Free Detergent Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

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 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.

Medical Silicone Processes Medical Silicone Processes

Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.

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FEATURED SUPPLIERS

Caplugs Caplugs

Caplugs, a global leader in protective solutions since 1948, offers extensive custom molding capabilities and a catalog of products available for same day shipment for the medical industry. With more than 1,300 medical customers, a series of ISO certifications, a Class 8 certified Clean Room and a stringent quality control process, Caplugs understands the unique challenges and needs of the medical field. Whether you need a custom molded solution or an in-stock component, our dedicated team of medical experts is available to guide you through the process.

SMC Ltd. SMC Ltd.

Passion for technology has driven SMC Ltd. to be a leading manufacturing partner to top medical OEM’s in the diagnostics, pharmaceutical and medical device markets. Services include program management, product launch/scale-up, product design, engineering, prototyping, strategic supply chain management, custom thermoplastics component manufacturing, assembly, reagent filling, pouching, pre-packaged drug handling, automation, testing, and packaging.

 EVENTS

Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Competency-Based Training in a GMP Environment – Results Based on Roles and Responsibilities March 27 - 27, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Audit Trail Generation and Review 2019 April 1, 2019
Fremont, CA
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance April 4 - 4, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FDA's New Import Program for 2019 April 9, 2019
Fremont, CA
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success April 9 - 9, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs April 11 - 11, 2019
Online Training; 1:00 - 2:30 PM EDT US
Duration:  90 minutes
Price:  $299 - Includes Bonus Handouts!
Aseptic Process Validation: Top-Tips for Compliance and Success April 17 - 17, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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