Med Device Online: Advancing human health by connecting …
Dielectric Laboratories is a global supplier of microwave and millimeter wave components for optical and wireless communications, military, medical, semiconductor, aerospace, and transportation markets.
ISO 10993-23 The “Step-Wise” Approach To Evaluate Potential …
May 12, 2021 · <p>The new ISO 10993-21:2021 specifies the procedure for the assessment of the biological irritating potential of medical devices, materials, or their extracts. It is relevant to all directly or indirectly contacting medical devices regardless …
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.
A New Approach To ISO 14971 For Better Medical Device Risk …
Oct 23, 2024 · 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 ...
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>
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>
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 The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).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>
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 ...
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>