Featured Editorial

  1. A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine 4/12/2024

    There are limitations to the currently available COVID-19 vaccines. An inhalable dry powder approach offers promising benefits, such as eliminating cold chain requirements, allowing for more widespread immunity.

  2. Understanding The New MHRA Requirements For Medical Devices In Great Britain 4/9/2024

    The U.K.’s MHRA has updated its transition arrangement dates for CE marked devices with regard to EU MDR compliance.

  3. A Holistic Approach To Your Medical Device's Usability 4/8/2024

    Medical device developers must plan and design for what happens once their device leaves the manufacturing facility. Consider how a device will make the journey to its intended users and how those users will work with the device.

  4. Breaking Through The Blood–Brain Barrier: The Rise Of Focused Ultrasound 4/5/2024

    Focused ultrasound can noninvasively, safely, and reversibly open the blood–brain barrier, overcoming a major obstacle for therapies targeting neurodegenerative diseases. Here's how.

  5. A Cost-Effective Approach To EU MDR Compliance 4/2/2024

    How can you be cost-effective in the face of the cost of compliance with the EU's Medical Device Regulation (MDR)? This article shares tips.

  6. Eying Up The Era Of Topical Biologics 3/19/2024

    Claris Bio’s phase 1/2 clinical trial in patients with Stage 2 or 3 Neurotrophic Keratitis (NK) is breaking new ground in the development of topically administered biologic therapies. 

  7. Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification 3/19/2024

    This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements.

  8. Super Generics: Market Trends In Europe 3/12/2024

    Super generics combine advanced formulations and delivery methods, and improved bioavailability, compared to traditional generics. This article shares market research trends in the market in Europe.

  9. New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis 2/29/2024

    On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.

  10. Exploring Biolistic Particle Delivery Systems 2/29/2024

    The main objective of biolistic particle delivery is to insert genetic material or other molecules into cells or tissues for diverse applications, including genetic engineering, gene therapy, and plant modification. The ability to target substances into specific cells enables researchers to investigate gene functionality, alter genetic traits, or explore novel therapeutic strategies.