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

HD Performance Handheld Infrared Camera: FLIR T1030sc HD Performance Handheld Infrared Camera: FLIR T1030sc

FLIR offers the new T1030sc Long-Wave Infrared Camera designed to capture images with 1024 x 768 pixels at 30 frames per second (fps). The camera provides high thermal sensitivity, fast raw data streaming, and a high speed interface (HSI) connection for streaming lossless HD radiometric imagery at 120 Hz or up to 480 Hz with windowing.

21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems 21 CFR Part 11 Data Integrity Software for Container Closure Integrity Testing Systems

PTI has developed a new standard for protecting, storing and presenting data generated from its line of non-destructive leak testers in the form of a software package called PTI Ethos.

Medical Device Prototyping & Design Services Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

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.

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.

Medical Micromolding Medical Micromolding

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

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FEATURED SUPPLIERS

REVOX Sterilization Solutions REVOX Sterilization Solutions

REVOX Sterilization Solutions is part of the Cantel Medical Corp.; a company dedicated to infection prevention and control.  Our in house experts include mechanical engineers, chemists, microbiologists, quality assurance and regulatory affairs professionals. The REVOX team will work to understand your challenges, concerns, and opportunities and provide expert insight to help you decide if REVOX Sterilization is the right sterilization solution for your product or product concept, and/or operational efficiency improvement goals.

 EVENTS

Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program March 21 - 21, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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!
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