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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.
A New Approach To ISO 14971 For Better Medical Device Risk …
2024年10月23日 · ISO 14971 is one of the most referenced and quoted risk analysis guidance documents in the medical device industry. 1 The guidance’s influence sometimes extends well beyond just medical devices. The purpose of this article is to reinterpret the risk model in Annex C of ISO 14971 using relational risk analysis (ReRA) to describe a better approach for understanding, analyzing, and managing not ...
Understanding The New MHRA Requirements For Medical Devices …
2024年4月9日 · 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 ...
2023年12月14日 · <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
2024年11月21日 · <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>
The Role Of The Contract Manufacturer Under The EU MDR & IVDR
2021年5月31日 · 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 ...
FDA Releases Guidance On Cybersecurity In Medical Devices
2022年5月31日 · <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 The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).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>
A Guide To UDI Device Label And Package Requirements
2014年11月24日 · <p>On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable.</p>
Emerging Trends in Ultrasound Imaging - Med Device Online
2022年6月15日 · <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 ...
AI-enabled Medical Devices In India Opportunities And Challenges
2024年5月7日 · 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 local ...