Showing items tagged as Medical Device

  • Is Your Design History File Prepared for an FDA Inspection?

    September 25, 2020 By David Butcher, Staff Writer

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

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  • Overview of ISO 13485 – Medical Device Quality Management System Requirements

    August 26, 2020 by James Jardine, Staff Writer

    Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.

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  • EU’s MDR Calls for Summary of Safety and Clinical Performance

    August 18, 2020 by Dave Jensen, Staff Writer

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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  • Software as a Medical Device – Upcoming Changes to the Australian Regulations

    July 17, 2020 by Belinda Dowsett, Quality Assurance Manager and Consultant

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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

    June 23, 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?

    May 26, 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

    May 12, 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

    April 30, 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

    April 23, 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

    March 12, 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

    January 16, 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

    January 7, 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

    December 10, 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

    November 21, 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

    November 19, 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

    September 19, 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

    September 17, 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

    August 29, 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

    August 21, 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

    May 29, 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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