FEATURED EDITORIAL

decision making, Byroad-GettyImages-532257428 Making The Call On Pre-Validated Packaging

The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? It depends.

  • The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.

  • An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  • We’ve all heard the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” This mindset needs to be fully integrated into the minds and systems of a company.

INDUSTRY INSIGHTS

  • Navigating Recent Changes To USP <788>

    A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.

A Risk-Based Approach To EO Residual Limits

ISO 10993-7:2026 replaces table-based EO residual limits with a risk-based framework that requires manufacturers to justify limits based on device-specific and patient-specific factors.

Why Micro Manufacturing Needs "Architecture" Not Just Production

Discover why micro molding requires a complete manufacturing architecture integrating design, tooling, automation, metrology, production, and packaging to achieve predictable, repeatable results at scale.

The People Who Turn An Idea Into A Deliverable Product

Drug developers and device engineers share more common ground than their distinct disciplines suggest, facing parallel pressures around design, safety, regulatory approval, and scalable performance.

8 Regulations Every Biotech & Pharma Quality Leader Must Know

Navigate essential biotech and pharma regulations safely. Learn how unifying global standards streamlines audits and accelerates development schedules.

SOLUTIONS

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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.

Cut the clutter, chaos, and compliance complications. Move to a modern compliance platform that your team will actually use.

To help you bring your medical products to market accurately and on schedule, Donatelle provides 24/7 assembly and packaging as part of their suite of integrated services. They have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.

FEATURED SUPPLIERS

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