Showing items tagged as Medical Device

  • What Verification and Validation Activities are Required for a First in Human Study?

    23 June, 2020 By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    26 May, 2020 by Gert W. Bos, PhD, Fraps, Executive Director and Partner, the QServe Group

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

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  • A Data-Centric Approach to Propel the Future of Device Innovation

    12 May, 2020 by Mike Rigert, Staff Writer, MasterControl

    Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.

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  • What 2019 Data Reveals About FDA’s 510(k) Program

    30 April, 2020 by Luis Jimenez, Vice President of Business Development, Brandwood CKC

    The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.

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  • 3 Trends That Can Improve Manufacturers’ Speed to Market

    23 April, 2020 by David Butcher, Staff Writer, MasterControl

    Technologies are evolving and maturing, and regulatory bodies are reacting to remove unnecessary roadblocks for device companies while protecting consumer safety. Manufacturing organizations that embrace these opportunities will be better positioned to achieve significant efficiencies in product discovery and development, regulatory compliance and, ultimately, speed to market.

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  • 3 Medical Device Trends for 2020

    12 March, 2020 by Mike Rigert, Staff Writer, MasterControl

    Advanced technology, market growth and regulatory disruption are creating an opportunity-rich but also demanding medical device space in 2020. An overview of some of the most impactful medtech trends of 2020 gives companies insights on how the industry is evolving and offers ways to flourish in a more data-driven ecosystem.

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  • Christmas Comes Early to Medtech: U.S. Repeals Device Excise Tax

    16 January, 2020 by Mike Rigert, Staff Writer, MasterControl

    With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.

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  • To Pre-Sub or Not to Pre-Sub? Weighing the Value of the FDA’s Pre-Submission Program

    7 January, 2020 by J. Lawrence Stevens, RAC and principal consultant, One Way Consultants

    The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.

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  • Innovation and Compliance Harmonize Perfectly at Cochlear

    10 December, 2019 by James Jardine, Staff Writer, MasterControl

    Cochlear’s cochlear implants are more than just groundbreaking medical devices — they’re a life-redefining means through which people with hearing loss to connect with the world. Learn how the company is bringing innovative products to more people in need by accelerating quality and compliance processes with robust digital solutions.

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  • The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

    21 November, 2019 by Mike Rigert, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.

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  • It’s A Charlie Brown Audit

    19 November, 2019 by David Jensen, Staff Writer, MasterControl

    Over the years, Charlie Brown and the Peanuts gang have regaled us with TV specials featuring their own brand of holiday celebrations. One show that never made it to the airwaves was the gang’s experience operating a medical device manufacturing plant that was having an audit. This article describes how that event played out.

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  • 3 Clinical Trends Shaping the Medical Device Space in 2019

    19 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    The medical device industry is changing at a pace that most in the industry are struggling to keep up with. And nowhere is that more evident than in medtech’s clinical research and trials space. Glean some of the hottest new clinical trends as we move into Q3 and Q4 of 2019.

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  • Uncertainty Regarding EU MDR Underscores Importance of Certification Preparation

    17 September, 2019 by Mike Rigert, Staff Writer, MasterControl

    Europe’s new regulation for medical devices, the Medical Device Regulation (MDR) takes effect May 26, 2019. Due to confusion regarding the regulation’s requirements and a lack of Notified Bodies to recertify medical devices under the new law, greater clarity is needed. Learn the latest on the developing situation and what med dev companies can do to prepare to recertify their devices.

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  • Deflating Common QMS Misconceptions: Your Transition from Class II to Class III Devices

    29 August, 2019 by Andrea Pilon Artman, Founder, SpectRA Compliance

    Medical device manufacturers are often confused about the regulatory requirements when expanding their product line from Class II devices to also include Class III devices. Learn what is and what is not required of your quality management system (QMS) and premarket approval application for Class III devices.

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  • 6 Tips for a Successful Transition to the EU MDR

    21 August, 2019 by Jenny Lin, Consultant, Brandwood CKC

    Considering the uncertainties surrounding the European Union’s implementation of the Medical Device Regulation (MDR) beginning in May 2020, many device makers are wondering how to proceed toward certification. Despite a lack of official guidance, there are several steps medical device manufacturers can do to prepare themselves to certify and implement Europe’s new regulations.

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  • FDA’s Plan to Replace QSR With ISO 13485: Pros and Cons

    29 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.

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  • Surviving the Perfect Storm – International Harmonization for Medtech

    22 May, 2019 by Grant Bennett, CEO, Brandwood Biomedical

    The evolution of regulatory changes in the European Union with it’s Medical Device Regulation (MDR), the U.K.’s Brexit, and changes in Canada and elsewhere are creating a global ripple effect in the medical device industry. These hurdles may cause uncertainty for device makers, but through careful preparation and planning, medtech companies adjust their strategies and approaches during this transitionary period.

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  • 2019 Med Device Trends: Digital Health Will Move Onward

    9 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    If this year’s Consumer Electronics Show (CES) is any indication of things to come, we can expect the role of medical devices in digital health to move onward and upward. The popular annual trade show attracted over 500 exhibitors of digital health products, including hundreds of medical devices.

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  • 2019 Med Device Trends: Products Most Likely to Shine

    9 April, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    Don’t expect a breakthrough technology such as 3D printing or AI-driven medical devices this year. Instead, industry experts anticipate that existing innovative products will gather momentum — among them: devices for minimally invasive procedures, light-therapy-based devices, and human cells, tissues, and cellular and tissue products (HCT/P).

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  • Bill of Materials Can Help Relieve Pain Points in Device Design Approval

    28 March, 2019 by Mike Rigert, Staff Writer, MasterControl

    Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.

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