FEATURED EDITORIAL

FDA Updates Several 510(k) Guidance Documents
FDA Updates Several 510(k) Guidance Documents

The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.

  • An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices
    An Intro To Prefilled Syringe Selection: Needle-Free And Dual-Chamber Devices

    This two-part article will provide an introduction to the three general prefilled syringe (PFS) types and will share important factors to take into consideration for your drug product. In this first part, we will discuss the needle-free PFS and the dual-chamber system.

  • RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward
    RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward

    This is the second article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

  • India To Enhance Oversight Of Medical Devices
    India To Enhance Oversight Of Medical Devices

    India's Central Drugs Standard Control Organization (CDSCO), the country’s national regulatory authority for both drugs and medical devices, is forming a new division that works exclusively with medical devices. Here’s what we know so far.

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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

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.

Hydrogels For Medical Devices Hydrogels For Medical Devices

Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.

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.

Medical Light Sources And Components Medical Light Sources And Components

SCHOTT Lighting and Imaging delivers medical light sources to help redefine the boundaries of medical innovation, and provide deeper insights in helping medical experts see more of what is relevant to their diagnoses and therapies. 

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.

  PolyJet 3D Printing Services PolyJet 3D Printing Services

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

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FEATURED SUPPLIERS

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.

Alconox, Inc. Alconox, Inc.

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

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!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works November 12 - 12, 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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