Industry Insights
-
Eurofins Medical Device Services Expands US Portfolio With New Ethylene Oxide Sterilisation Solution
3/31/2025
Eurofins’ San Jose EO sterilization site offers fast, high-quality sterilization services for medical devices, ensuring compliance with FDA, cGMP, ISO 11135, and new EPA regulations.
-
Ophthalmic Delivery Systems: Testing For Regulatory, Patient Compliance
3/31/2025
Explore ophthalmic drug and device testing, focusing on regulatory and patient compliance, including design considerations, testing methodologies, safety, and efficacy for medical device development.
-
Medical Tubing Materials, Dimensions, And Materials
3/24/2025
IDEX Health & Science designs precision tubing with tight tolerances for medical and life sciences applications, offering custom materials, colors, and dimensions through advanced extrusion technology.
-
Success In Times Of Crisis: A Journey From Concept To Market In 8 Months
3/20/2025
Medbio ensures seamless tool transfers for medical device manufacturing by assessing tools, implementing improvements, and minimizing downtime to maintain quality, efficiency, and regulatory compliance.
-
How High-Energy Capacitor Banks Drive Plasma Research
3/12/2025
High-energy capacitor banks power cutting-edge plasma research, enabling plasma generation, heating, and confinement in fusion experiments and pulsed energy applications like the National Ignition Facility’s laser systems.
-
Introduction To Laser Filters
3/7/2025
Laser filters selectively transmit, block, or manipulate laser wavelengths for applications like Raman spectroscopy, fluorescence microscopy, and laser scanning. Types include clean-up, edge, notch, and dichroic filters.
-
Introduction To Edge Filters
3/7/2025
Edge optical filters selectively transmit or block specific wavelengths. They are essential in fluorescence imaging, Raman spectroscopy, and laser applications, with specialized tunable and dichroic beamsplitter variants.
-
FAQs On The Revised EU GMP Annex 1: Volume 2
3/5/2025
Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof.
-
FAQs On The Revised EU GMP Annex 1: Volume 1
3/5/2025
The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.
-
Meeting Annex 1: A Proactive Approach To Regulatory Compliance
3/4/2025
It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.