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 […]
Preparing for the FDA’s QMSR: Your Guide to Compliance Success “The only constant in life is change.” Those words, often attributed to the Greek philosopher Heraclitus, seem especially true in the medical device industry. Industry veterans have experienced a constant evolution of the regulations over the past 10 years. There was the update to ISO […]
Simplify Airborne Systems Lifecycle Milestones with Categories Gain Clarity, Reduce Risks, and Stay Compliant. Struggling to keep track of deliverables across complex aerospace projects? You’re not alone. Managing deadlines and milestones often feels like navigating a maze of documents, spreadsheets, and shifting priorities. In this webinar, you’ll discover how Jama Connect®’s Categories feature can bring […]
Empowering Complex Medical Device and Life Sciences Development with Responsible AI and Machine Learning Artificial intelligence (AI) and machine learning (ML) are transforming industries across the globe, and the medical device and life sciences sectors are no exception. Today, the development of complex medical devices is being accelerated and optimized with the integration of responsible […]
Navigating the New DOGE Impacted FDA: How MedTech Companies Can Build a Competitive Advantage The Center for Devices and Radiological Health (CDRH) is a key branch of the FDA that is responsible for ensuring the safety and effectiveness of medical devices. Companies interact with the CDRH through premarket submissions, quality inspections, recalls, and a variety […]
The Evolution of FDA Design Controls (21 CFR 820.30) and How Jama Software Supports Compliance History of US Regulation The US medical device industry is governed by a complex framework of regulations designed to ensure the safety and effectiveness of products. A thorough understanding of this history provides valuable insights into the development of 21 […]
How Jama Connect® Supports Trade Compliance for Vehicle Connectivity Systems In this short demo, industry expert Fabian Koark walks through how Jama Connect helps organizations meet evolving trade compliance regulations — specifically the new 2025 update to U.S. Federal Regulation 15, targeting vehicle connectivity systems. Learn how to classify architectural elements by trade restriction, integrate […]
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