What is ISO 13485? A Simple Guide for Medical Device Professionals Introduction If you’re a medical device professional, you’ve very likely heard of ISO 13485. But reading the standard can feel like diving into a boring, theoretical document that seems designed to slow you down. You have products to develop and deadlines to meet. You […]
Jama Connect® Supports Export-Restricted and ITAR Use Cases Organizations operating under export restriction and/or International Traffic in Arms Regulations (ITAR) face unique challenges when selecting collaboration tools for product development. These regulations, designed to control the export of defense-related articles and services, require stringent data handling and access controls that many standard software platforms cannot […]
Write Clear Design Inputs: A Practical Guide to ISO 13485 Compliance In the medical device industry, the clarity of your design and development inputs is vital. Unclear or conflicting requirements can slow down development and make it harder to meet regulatory expectations. This session offers practical guidance to help ensure your design inputs are clear, […]
Streamline Your Program Management: Techniques to Manage Work Breakdown Structures (WBS) In aerospace and defense program management, success hinges on coordinating complex, interconnected projects while maintaining clear visibility across your entire program. When managing multiple systems and stakeholders, your work breakdown structure becomes the foundation that either strengthens or undermines your project’s success. In this […]
Making Sense of ASQMS: A New Standard for Automotive Software Quality The Next Automotive Software Standard Is Here. Are You Ready for ASQMS? The shift toward software-defined, new energy, and intelligent vehicles is transforming the automotive industry. As vehicles become more reliant on complex software to power advanced features, autonomy, and connectivity, the need for […]
AI in MedTech: Transforming Device Innovation and Quality No matter where you turn these days, it is nearly impossible to escape the influence of AI. The MedTech industry is no different and stands at the brink of an AI revolution. From smarter devices to streamlined quality systems and even regulatory reviews, AI is poised to […]
A Quality Leader’s Guide: How to Improve Quality Metrics in Medical Device Development As a Quality leader in the medical device industry, you face constant pressure to not only ensure products are safe and effective, but to make sure your team is staying compliant with all applicable regulations. Passing audits, hitting project deadlines, and achieving […]
Streamline Medical Device Postmarket Surveillance by Taking a Full Lifecycle Approach with Jama Connect Postmarket surveillance (PMS) is an expected regulatory activity that plays a vital role in ensuring the safety and effectiveness of medical devices after they reach the market. The key to an effective PMS program is to ensure that the requirements and […]
QMSR is Coming: How to Prepare for FDA’s Alignment with ISO 13485 Prepare for QMSR: Step-by-Step Guidance for FDA’s ISO 13485 Alignment The FDA’s long-anticipated Quality Management System Regulation (QMSR) goes into effect in February 2026, marking a major shift by aligning FDA requirements with ISO 13485. This update presents both challenges and opportunities to […]
Biofidelity, Genomic Technology Innovator, Selects Jama Connect to Inject Efficiency and Adaptability into the Requirements and Test Management Process Customer Story Biofidelity chooses Jama Connect to enhance the process previously managed manually with Jira and documents. Biofidelity, headquartered in Cambridge, United Kingdom, provides innovative technologies that unleash the potential of genomics for fast and […]
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