Showing items tagged as Medical Device

  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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).

    Full story
  • 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.

    Full story
  • Top Regulatory Trends Affecting Med Dev in Asia-Pacific Moving into 2019

    26 February, 2019 by Grant Bennett, CEO, Brandwood Biomedical

    Despite a virtual kaleidoscope of continual regulatory fluctuations, 2019 presents some potentially very attractive market expansion opportunities in Asia-Pacific, including China, India, Australia and Japan. Get a comprehensive overview of device markets and their promising potential.

    Full story
  • 2019 Med Device Trends to Watch For: Regulatory Changes

    14 February, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

    Full story
  • 4 Tech Trends to Watch in Manufacturing Device History Records

    7 February, 2019 by David Butcher, Staff Writer, MasterControl

    As medical device manufacturers try to understand exactly how and where to use constantly evolving digital technologies to achieve better operational and quality results, they must keep a close eye on changes in automation and be agile to respond to these developments. Explore four trends the med device industry can expect in 2019 and beyond, particularly as they relate to manufacturers’ device history records (DHRs).

    Full story
  • 4 Common Pains in Managing Device History Records

    22 January, 2019 by David Butcher, Staff Writer, MasterControl

    In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). The DHR is literally the history of the device, and manufacturers in the business of medical technology face common challenges when using a paper-based or partially electronic system.

    Full story
  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    2 January, 2019 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

    Full story
  • 5 Keys to Helping Your Device Company Gain MDSAP Certification

    2 January, 2019 by Jean-Christophe Gourmanel and Tifany Desprez, Apsalys, a MasterControl Partner

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

    Full story
  • Modernizing the FDA's 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 2

    19 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This is Part 2 of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. This blog post discusses the pros and cons of the program in general and the dangerous loophole in the equivalence approach.

    Full story
  • Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 1

    12 December, 2018 by Alex Butler, Manager of Medical Device Solutions, MasterControl

    This blog post is the first of a series of three articles on the need to modernize the FDA’s 510(k) clearance process. Part 1 discusses key points of the ICIJ investigation on the medical device industry, the FDA’s response, and the implications of this hot-button public debate in the near future.

    Full story
  • BraveHeart Team Emphasizes Quality-First Approach

    16 October, 2018 by David Jensen, Staff Writer, MasterControl

    One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.

    Full story
  • De Novo Becoming Faster and Easier Pathway to Market

    25 October, 2018 by David Jensen, Staff Writer, MasterControl

    There are many pathways to bring a medical device to market. The 510(k) and premarket approval (PMA) are the most common, while the de novo pathway is less popular. Advances in technology and changes in regulatory standards are making the de novo a more attractive option.

    Full story