FEATURED EDITORIAL

Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations
Applying Lean Thinking To Support Processes in MedTech, Biotech Organizations

This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”

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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

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.

pco.dicam C1: intensified sCMOS camera pco.dicam C1: intensified sCMOS camera

PCO introduces the new pco.dicam C1 and as the first intensified camera systems to exploit the full performance inherent to scientific CMOS sensor technology. The camera features optical coupling of 25 mm high resolution image intensifiers, an excellent high efficiency tandem lens system, and a 16 bit 4 MPix sCMOS sensor.

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.

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.

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.

Flexible Electronic Assemblies For Medical Ultrasound Imaging Flexible Electronic Assemblies For Medical Ultrasound Imaging

Micro Systems Technologies (MST) offers an array of highly reliable flex circuit assembly solutions for ultrasound imaging used in diverse medical diagnostic areas. From 1D to 3D and beyond, the advanced flexible electronic assemblies deliver enabling capabilities in PCB manufacturing and assembly technologies.

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FEATURED SUPPLIERS

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.

Donatelle Donatelle

Donatelle has been in business over 45 years providing medical device contract manufacturing services helping companies develop innovative and life-saving products. 

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

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
Cleanroom Microbiology – A Foundational Introduction November 5 - 5, 2019
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Implementing a Robust Change Control Program – Key Elements for Process and Documentation Compliance November 6 - 6, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
21 CFR Part 11: Understanding the ERES Regulation for Compliance Success November 13 - 13, 2019
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control November 14 - 14, 2019
1pm-2:30pm EST, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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!
Drug Delivery Partnerships (DDP) March 30, 2020 - April 1, 2020
Orlando, FL
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