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Dielectric Laboratories is a global supplier of microwave and millimeter wave components for optical and wireless communications, military, medical, semiconductor, aerospace, and transportation markets.
Understanding The New MHRA Requirements For Medical Devices …
Apr 9, 2024 · Recent developments at U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) as a result of EU MDR extensions and other factors have caused the agency to update its transition arrangement dates for CE marked devices.
Key Considerations In "Intended Use" And "Indications For Use ...
Dec 14, 2023 · <p>You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.</p>
Medtech: Capitalize On These 4 Trends To Thrive In 2025
Nov 21, 2024 · <p>Leaders from Ernst & Young deliver intel on the four biggest trends that impacted the medtech industry in 2024 that savvy medtech companies will seize for success in 2025.</p>
FDA Releases Guidance On Cybersecurity In Medical Devices
May 31, 2022 · <p>The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).</p>
AI-enabled Medical Devices In India Opportunities And Challenges
May 7, 2024 · The medical device market in India is one of the best places for the world to tap into since the early 2000s.Many are watching the evolution of the medical device industry in India, with McKinsey and Co. predicting that competition in the medical device space will follow a trend that has occurred in other industries: multinational corporations (MNCs) establish the market, followed by …
Emerging Trends in Ultrasound Imaging - Med Device Online
Jun 15, 2022 · <p data-pm-slice="1 1 []">We are close to a new era in ultrasound technology. From helping healthcare specialists detect diseases such as cancerous cells to showing real-time images inside the mother’s womb, this technology is a go-to way for specialists to deal with a range of diseases and tasks. Let's take a closer look at the 5 emerging technologies impacting this field's ...
Understanding The FDAs New Medical Device Cybersecurity …
Nov 20, 2023 · <p>The FDA cybersecurity requirements for medical “cyber devices” went into effect on Oct. 1, 2023. The FDA has made it clear that it cannot even accept submissions that don’t contain the cybersecurity requirements. This article shares 4 steps to navigate the new requirements.</p>
The Role Of The Contract Manufacturer Under The EU MDR & IVDR
May 31, 2021 · By Mark Durivage, Quality Systems Compliance LLC. Regulation (EU) 2017/745 Medical Device of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC Active Implantable Medical Devices Directive (EU AIMDD) and 93/42/EEC Medical Device ...
The Emerging Business Models For Digital Therapeutics
Jan 16, 2024 · <p>Digital therapeutics (DTx) leverage technology to deliver evidence-based treatments. Due to reimbursement barriers and slow market adoption, players in the space are pivoting to new business models. This article shares details.</p>