FEATURED EDITORIAL

Mexico on binary code, modern technology-GettyImages-1437897039 The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail

While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

INDUSTRY INSIGHTS

Cybersecurity And Medical Devices: Understanding Classes And Risk

A device's FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require independent security assessments to protect patient data and ensure compliance.

Part II: Defining The Dye Ingress Operating Window

Learn about the viscosity-driven limits of dye ingress testing, translating qualitative constraints into a quantitative feasibility boundary shaped by defect size, pressure behavior, and plunger mechanics.

Safeguarding Biologic Integrity Through Enhanced Component Compatibility

For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.

Optimizing Syringe Performance For Reliable Drug Delivery

Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.

SOLUTIONS

MagnaAmp® is a self-contained biological indicator ampoule for monitoring steam sterilization of liquids in ampoules, large containers, or washer sterilizers.

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Manufacture high-quality products at any level of compliance.

FEATURED SUPPLIERS

PTI is a leading manufacturer of inspection equipment and a services solutions provider. We specialize in the development of sensory technologies for container closure integrity testing (CCI), package integrity, and seal quality inspection. PTI’s Life Science CCI services provide regulatory guidance and support throughout the pharma product lifecycle. We serve the Life Science industries encompassing Pharmaceutical, Biotech, & Medical Device.

Leading inspection technologies include High Voltage Leak Detection (HVLD), Vacuum & Pressure Decay, Airborne Ultrasound, and Helium leak testing. These innovations find versatile applications across a wide range of packaging formats, including pre-filled syringes, vials, ampoules, cartridges, autoinjectors, IV bags, blister packs, pouches, and numerous other packaging configurations.

PTI’s non-destructive technologies are designed for applications spanning R&D lab testing, automated inspection, and solutions for technology integration.

Dielectric Laboratories is a global supplier of microwave and millimeter wave components for optical and wireless communications, military, medical, semiconductor, aerospace, and transportation markets. We are a manufacturer of High-Q Multi-Layer capacitors (MLC) and Single-Layer capacitors (SLC), Resonators, Filters, Broadband DC blocks, Thin Film components, and Custom ceramic components. In 2004, DLI acquired Voltronics Corporation, a world leader in precision variable capacitors.

MED DEVICE ONLINE CONTENT COLLECTIONS

21_09_MDO_MedtechAI_Ebook_300x200

 

Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

More Content Collections