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

  • What's Ahead For Medical Device Manufacturers

    Medical device manufacturers face growing complexity in 2026, needing stronger partnerships, advanced biomaterials, and resilient supply strategies to meet shifting patient, regulatory, and global market demands.

The Strategic Power Of Medical Device Coatings

Medical device coatings are shifting from basic finishes to strategic tools that boost performance, safety, sustainability, and innovation through stronger partnerships, smarter materials, and collaborative development.

Robotics And AI In Pharma: Driving The Next Wave Of Innovation

Adopting AI and robotics enhance sterility and regulatory compliance and enable real-time decision-making and reduce human-borne contamination, ensuring the safe production of complex therapies.

Managing Risk In The Most Complex Combination Device Format

Autoinjectors add mechanical forces and interactions that change how container closure integrity must be evaluated. Learn why device complexity creates new risks and how testing strategies must adapt.

EO Sterilization In Transition: Regulatory Shifts And Industry Impact

Ethylene oxide sterilization is transforming. Manufacturers must adopt risk-based approaches and optimized cycles to meet rigorous emission controls and patient safety limits for sensitive populations.

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

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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.

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