FEATURED EDITORIAL

ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective
ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective

The organization’s QMS must have an overarching quality plan -- one that details the elements to be implemented to achieve a successful transition – and must work directly with all the stakeholders involved.

  • Think Your Accessory Isn’t A Medical Device? Think Again.
    Think Your Accessory Isn’t A Medical Device? Think Again.

    The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.

  • What Is GDPR’s Effect On Medical Devices?
    What Is GDPR’s Effect On Medical Devices?

    The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:

  • AI Provides Help For The Sandwich Generation
    AI Provides Help For The Sandwich Generation

    Catalia Health's AI-infused personal healthcare companion, Mabu, has conversations with patients every day to manage their treatment and gather data about their progress.

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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

Laser Beam Profilers Laser Beam Profilers

Laser beam profilers are the optimal solutions for increasing chances of success in the design or applications of new lasers, or when a laser system is no longer meeting the desired specifications. Ophir Photonics offers a wide range of beam profiler choices including CCD and CMOS cameras, scanning slit sensors, InGaAs and pyroelectric cameras, and pinhole and knife edge sensors.

Caplugs Custom Medical Molding Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

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.

Rapid Tooling And Medical Device Prototyping Rapid Tooling And Medical Device Prototyping

Donatelle’s rapid tooling and prototyping services help accelerate the design process and bring critical medical device products to market – faster. With an experienced team of engineers, mold designers, machinists, and toolmakers, they are able to produce near-net shape parts with near production tolerances, machined or molded, in as little as a few days.

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.

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.

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FEATURED SUPPLIERS

The Lee Company The Lee Company

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

Battelle Battelle

Medical Product Development|Commercialization|Market Research|Industrial Design

MDO-FTE-bmarshall

 EVENTS

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!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Pediatric Clinical Trials: Special Considerations and Requirements June 4 - 4, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements June 26 - 26, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
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