Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)
Seeking A Smooth Transition To The New EU MDR? (Then Start Complying Now)

The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times. 

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  • How Many FDA Premarket Applications Are Necessary For Your Combination Product?
    How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

Validation: A Key Stage In Mobile Health Development

To enter the rapidly growing mobile health space, companies must overcome the Mobile Health Development-crucial hurdle of validation. This process demonstrates that the app – in combination with the underlying technology platform / device – performs comparably to traditional products on the market..

IoT-Enabled Medical Devices Are The Wave Of The Future

Winning in the medical devices market of the future requires mastering advanced technologies – or finding a partner with these capabilities. The global Internet of Things (IoT) in healthcare market is forecasted to reach $410 billion by 2022. To succeed in this arena, device companies need to stay out in front of manufacturing innovations so they can quickly integrate information technology (IT) functionality into their products, accelerate time to market and control costs.

Using A Component Management Process To Scale Up Manufacturing Of Drug Delivery Devices

The best practice for fitting multiple parts into a single assembly at tight tolerances is to choose a single component supplier with a sufficient array of core competencies in advanced device manufacturing methods. The chosen supplier should also utilize a well-designed component management process that includes close attention to important elements, proper planning, and high performance levels to provide an affordable, highly scalable drug delivery device.

Segmentation Of The Diagnostics Market

The in vitro diagnostics (IVD) market is commonly segmented by techniques, products, application, end users, and geography. To better navigate the IVD diagnostic market landscape, understanding and recognizing how each segment is distinct, yet related to one another is critical for the company that wants to optimize its opportunities within this market.

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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. 

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.

  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.

Electro-Mechanical Assembly Electro-Mechanical Assembly
Corry Micronics offers a wide variety of electro-mechanical assembly services, including...
Metal Additive Manufacturing Metal Additive Manufacturing

PTI offers metal additive manufacturing to improve productivity and quality for sinks, over-long cycles, and the so called ‘impossible’ cooling challenges. PTI uses a power bed fusion process aided by 3D data that supplies a thin layer of metal powder to the machine base plate. Designers then use a laser beam to sinter the metal powder to form shapes, allowing creation of designs not possible with the subtractive manufacturing process.

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.

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Heatron, Inc. Heatron, Inc.

Heatron was founded in 1977 and established a solid business in heating component design and manufacturing.  Our mission to help our customers accelerate their product development process by offering high performance products that differentiates them. With expertise in a multitude of key thermal technologies, our products are engineered to withstand the extraordinary demands placed on them.

FMI, Inc. FMI, Inc.

FMI is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.



  • Philips To Acquire Brain Monitoring Company Electrical Geodesics, Inc.

    Royal Philips , a global leader in health technology, recently announced an agreement to acquire Electrical Geodesics, Inc. (EGI), a US-based medical device company that designs, develops and commercializes a range of non-invasive technologies used to monitor and interpret brain activity. EGI’s portfolio of EEG hardware, software and acquisition sensors will complement Philips’ existing portfolio of imaging technologies (e.g. MRI and PET-CT) and advanced informatics (e.g. IntelliSpace Portal) for neurological applications.

  • FDA Clears First RF Ablation Treatment For Osteoarthritis Knee Pain
    FDA Clears First RF Ablation Treatment For Osteoarthritis Knee Pain

    The U.S. Food and Drug Administration (FDA) has approved the first and only radio frequency (RF) treatment to be cleared specifically to alleviate chronic knee pain due to osteoarthritis.

  • MKS' Ophir® Business Unit Announces Large Array Laser Beam Profiling Camera With Quick And Easy USB Interfacing
    MKS' Ophir® Business Unit Announces Large Array Laser Beam Profiling Camera With Quick And Easy USB Interfacing

    MKS Instruments, Inc., a global provider of technologies that enable advanced processes and improve productivity, has announced the Ophir® Pyrocam™ IV USB, a laser beam profiling camera that allows users to see their laser beam for dynamic alignment and proper operation. The camera features a 320 x 320 pixel pyroelectric array that can profile beams up to 1 inch (25 mm) without the need for reduction optics. It also includes a new USB 3.0 interface that provides a quick and easy connection to PCs for beam analysis, 2D and 3D beam display, as well as trending, data logging, and storage.

  • Exactech’s Computer-Assisted Shoulder Arthroplasty Tech Gains FDA Clearance

    Exactech, Inc., a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced recently it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS Shoulder Application

  • FDA Grants HUD Designation To Novocure’s Tumor Treating Fields (TTFields) Delivery System

    Novocure announced recently that United States Food and Drug Administration (FDA) has designated it’s Tumor Treating Fields (TTFields) delivery system as a Humanitarian Use Device (HUD) for the treatment of pleural mesothelioma.

  • Shockwave Medical’s Coronary Lithoplasty System Earns CE Mark

    Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, recently announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease.

  • Cook Medical’s Esophogeal Repair Device For Infants Cleared By FDA

    The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia.

  • Medtronic Options QT Vascular’s Chocolate PTA Balloon Catheter

    QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today that it has entered into an asset purchase option agreement ("Option Agreement") with Medtronic, for the acquisition of the Group's non-drug coated Chocolate® PTA.

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