LEAD STORIES

Implementing UDI Direct Marking

Direct marking is one part of FDA’s Unique Device Identification (UDI) rule, and it has a set of compliance dates that may differ from the labeling and Global UDI Database (GUDID) submission dates. The recently published draft guidance document Unique Device Identification: Direct Marking of Devices restates some requirements for direct marking and clarifies some issues. The UDI system has three major elements: adding a UDI to the product , loading a large dataset to FDA’s public database (the GUDID), and updating the quality system procedures.

  • Boston Scientific Wins FDA Clearance, CE Mark For TAVI/R Guidewire
    Boston Scientific Wins FDA Clearance, CE Mark For TAVI/R Guidewire

    Boston Scientific has won U.S. Food and Drug Administration (FDA) and CE Mark approval for its second-generation Safari2 Guidewire, used in the placement of commercially available transcatheter aortic valve implantation or replacement (TAVI/R) devices.

  • How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 1
    How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 1

    A number of well-publicized quality issues have prompted international regulators and standards organizations to require risk mitigation as part of a manufacturer’s quality management system. Additionally, outsourcing has become ubiquitous across the medical device supply chain. As a result, medical device companies now are re-evaluating their supplier management strategies, drilling into the underlying factors behind quality issues. In this article, I will explain how medical device manufacturers can address these issues by incorporating risk assessment into their supplier quality management plan.

INDUSTRY PERSPECTIVES

  • Implementing UDI Direct Marking
    Implementing UDI Direct Marking

    Direct marking is one part of FDA’s Unique Device Identification (UDI) rule, and it has a set of compliance dates that may differ from the labeling and Global UDI Database (GUDID) submission dates. The recently published draft guidance document Unique Device Identification: Direct Marking of Devices restates some requirements for direct marking and clarifies some issues. The UDI system has three major elements: adding a UDI to the product , loading a large dataset to FDA’s public database (the GUDID), and updating the quality system procedures.

  • How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 1
    How To Incorporate Risk Management In Medtech Supplier Quality Management, Part 1

    A number of well-publicized quality issues have prompted international regulators and standards organizations to require risk mitigation as part of a manufacturer’s quality management system. Additionally, outsourcing has become ubiquitous across the medical device supply chain. As a result, medical device companies now are re-evaluating their supplier management strategies, drilling into the underlying factors behind quality issues. In this article, I will explain how medical device manufacturers can address these issues by incorporating risk assessment into their supplier quality management plan.

  • Medical Sensors Primed To Take A Big Leap Forward
    Medical Sensors Primed To Take A Big Leap Forward

    The medical sensors of the future may be closer than you think. New advances in materials science, device engineering, and data analytics are coming together to make the next generation of medical sensors smaller, smarter, and more powerful than ever before. Here are four trends to watch in medical sensor development.

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FROM THE EDITOR

  • New Insights On Med Device Market Consolidation
    New Insights On Med Device Market Consolidation

    If your company is considering M&A as a solution to the med device market pressures, you need to understand the challenges ahead. I sat down recently with Steve Cottrell, the new president of Maetrics Life Sciences Consulting, to discuss his thoughts on the issue.

  • Companies To Watch: Pulse Therapeutics
    Companies To Watch: Pulse Therapeutics

    Pulse Therapeutics has developed a mechanical thrombolysis technology that accelerates the delivery of clot-busting drugs to a clogged artery. The Magnetically Enhanced Diffusion (MED) System consists of intravenously administered nanoscale iron particles and a patient-side workstation, whose rotating magnet induces the particles to spin within the bloodstream. This activity creates flow towards the clot in otherwise stagnant vessels, bringing medications to the clot site 40 times faster than normal. The company has filed an early feasibility investigational device exemption (IDE) with the FDA, and anticipates beginning clinical trials to evaluate the device for stroke treatment later this year.

  • 3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In
    3 Top Trends Driving Medical Device Design In 2015 — Experts Weigh In

    What factors should you consider before designing your next medical device? What capabilities will end users request (or demand?) from new devices in the coming months? What design approaches are your peers taking? What types of designs will be successful in the future?

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WHITE PAPERS & CASE STUDIES

  • 5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

    If you are developing a medical device in the United States, there is a good chance your path to market involves a FDA 510(k) submission. Within the past year, I’ve had the pleasure of authoring a couple FDA 510(k) submissions on my own from scratch, and I have learned a ton from these experiences. FDA expectations for 510(k)s are dramatically different from when I started my career. Let me share some things I’ve learned.

The Multiplier Effect Of Drug-Device Convergence

First-generation drug-device pioneers could not have envisioned today’s landscape. The growing convergence between medical devices, pharmaceuticals, and biologics is transforming these once-separate market sectors, not to mention the state of health care and our quality of life. The global market for drug-device combinations is on track to generate $115 billion in market value by 2019. Thus, opportunity — and demand — abounds for effective treatments combined with innovative drug delivery methods.

Adhesives For Gentle Removal From Skin

Berry Plastics has developed a new medical pressure sensitive adhesive (PSA) and tape designed to reduce pain from removal on a variety of different skin types. This white paper describes information about the PSA, the testing process for gentle skin removal, and its testing for strong adhesion.

5 Things To Know Before Entering The Chinese Medical Device Market

The Chinese medical device market, according to statistics and economic forecast, is an increasingly attractive place to invest because of many interrelated factors, described more extensively in the first article in this series, Chinese Medical Device Market: Opportunities And Challenges.

Product Qualification for Gamma Processing

There are many steps and considerations for the qualification of new medical devices in line to be processed with gamma radiation. The overall steps include the materials selection, manufacturing and product controls, dose setting, dose mapping, establishing routine processing specifications, dose auditing, and revalidations. This is an approximate step-by-step process, and it should be recognized that there may be considerable overlap and/or changes between one or more steps.

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PRODUCT SHOWCASE

Electro-Optical and Opto-Mechanical Assemblies for Medical/Life Sciences

Electro-Optical and Opto-Mechanical Assemblies for Medical/Life Sciences

Zygo’s Electro-Group provides design, manufacturing, and assembly engineering services for electro-optical and opto-mechanical assemblies used in medical and life science applications.

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

For the person with diabetes in need of insulin, the heart patient awaiting a monitor or the individual expecting critical lab results, a delay of even one day isn't acceptable. Timely delivery of medical supplies or medication could mean the difference between recovery and relapse.

Solenoid Valves: LFV Series

Solenoid Valves: LFV Series

The LFV Series is made up of 5 styles of solenoid valves available in standard and low pressure models. These valves are designed with a contoured path flow to minimize damage to “delicate” fluids, and a smaller internal volume to reduce the fluid amounts necessary to fill a system, and sample and reagent requirements.

Low Profile Miniature Positioner: MX80S Stage

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

Detojet: Low-Foaming Liquid Detergent

Detojet: Low-Foaming Liquid Detergent

Concentrated, biodegradable, and disposable, this low-foaming heavy-duty detergent provides high-performance results for cleaning machinery. Use it to pass your cleaning validation tests for lab accreditation and plant inspection approval.

Broadband RF Amplifier for EMC Compliance Testing: 25S1G6AB

Broadband RF Amplifier for EMC Compliance Testing: 25S1G6AB

The 25S1G6AB is a broadband RF amplifier ideal for use in EMC compliance testing. It covers the 1-6 GHz frequency range, provides 25 Watts of output power, and is just one model in a suite of class AB solid state amplifiers that can be used in medical equipment testing.

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LATEST HEADLINES

  • Stryker, St. Jude, Boston Scientific’s Q2 Sales Rise
    Stryker, St. Jude, Boston Scientific’s Q2 Sales Rise

    Second-quarter earnings reports from medical device companies show Stryker Corporation increased sales across three segments, while St. Jude Medical and Boston Scientific overcame sluggish sales in heart rhythm management to post modest overall earnings growth. Several other top companies, including Johnson & Johnson, Medtronic, and Becton, Dickinson and Company (BD), have yet to post their Q2 earnings reports.

  • Tiny Mechanical Wrists Could Expand Needlescopic Surgery Options
    Tiny Mechanical Wrists Could Expand Needlescopic Surgery Options

    Vanderbilt scientists have added a new innovation to their existing steerable needle technology: a tiny flexible wrist.  The technology will make it possible to perform even more delicate surgical procedures, such as suturing and tissue resection, using minimally invasive micro-laparoscopic techniques.

  • Cadence, Inc. Celebrates 30 Years of Manufacturing Excellence
    Cadence, Inc. Celebrates 30 Years of Manufacturing Excellence

    Cadence, Inc. has recently announced its 30 year anniversary in business. The company was founded in 1985 under the name Specialty Blades by the engineer Martin Lightsey. Cadence, Inc. has broadened its capabilities and services over the years with a focus in the medical device and life science markets. 

  • New Bionic Hand Uses “Smart Wires” To Mimic Human Muscles
    New Bionic Hand Uses “Smart Wires” To Mimic Human Muscles

    German scientists have introduced a bionic hand with muscles made from bundles of hair-thin “smart wires.” Though the technology is still in its prototype phase, engineers hope to develop their design into prosthetics that are lighter, less cumbersome, and more “natural.”

  • Boston Scientific Wins FDA Clearance, CE Mark For TAVI/R Guidewire
    Boston Scientific Wins FDA Clearance, CE Mark For TAVI/R Guidewire

    Boston Scientific has won U.S. Food and Drug Administration (FDA) and CE Mark approval for its second-generation Safari2 Guidewire, used in the placement of commercially available transcatheter aortic valve implantation or replacement (TAVI/R) devices.

  • New Senate Bill Cuts Red Tape For Medicare Patients Who Want To Self-Pay
    New Senate Bill Cuts Red Tape For Medicare Patients Who Want To Self-Pay

    A new bill proposed in the Senate seeks to eliminate the red tape that currently exists between Medicare patients and life-saving, innovative treatments. The Accelerating Innovation in Medicine (AIM) Act, drafted by a bipartisan group of U.S. senators, would streamline access to FDA-approved medical devices for patients wishing to self-pay, accelerating the collection of clinical data to be used in future Medicare coverage decisions.

  • MHRA Issues Draft Guidance On Re-Manufacturing Single-Use Devices
    MHRA Issues Draft Guidance On Re-Manufacturing Single-Use Devices

    The Medicine and Healthcare Products Regulatory Agency (MHRA) has released draft guidance on the re-manufacturing of single-use devices (SUDs) in the United Kingdom. The UK regulator is accepting public comments for review until Sept. 1, 2015, and final guidance will be available by the end of 2015.

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UPCOMING TRAINING COURSES

Project Management: Best Practices for Validation & Regulatory Projects

August 5, 2015
1pm-2:30pm EDT, Online Training

Medical Device Complaint Handling and MDR Reporting

August 11, 2015
1pm-2:30pm EDT, Online Training

Cloud Computing In A GxP Environment: Three Key Success Factors

August 13, 2015
1pm-2:30pm EDT, Online Training

21 CFR Part 11: Understanding the ERES Regulation for Compliance Success

August 25, 2015
1pm-2:30pm EDT, Online Training
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FEATURED SUPPLIERS

STERIS Isomedix Services

STERIS Isomedix Services

STERIS Isomedix Services has been committed to providing contract sterilization services to the medical device, pharmaceutical, consumer, and industrial communities for over 40 years. Blending industry-advanced technology with a team approach to Customer service, STERIS Isomedix Services offers the industry’s most comprehensive advantage, encompassing radiation and ethylene oxide sterilization.