Prepare Your Quality Management System for QMSR Compliance by February 2026
With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current Quality System Regulation (QSR) and align with ISO 13485:2016, marking a notable evolution in quality management practices for medical device production. Read more »
Outsourcing with Confidence: A Guide to Successfully Hiring Specialty Expertise Consultants in Healthcare
Outsourcing, partnering, or hiring specialty expertise consultants—regardless of the term used, this practice is becoming increasingly prevalent in the healthcare industry. Faced with budget cuts, downsizing, and layoffs, manufacturers of drugs, medical devices, biologics, and combination products are turning to external consultants with specialized expertise and a deep understanding of ever-changing quality regulations. This approach allows these companies to supplement their internal teams cost-effectively. Read more »
Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare
The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.
This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.
Read more »
Enhancing Quality Processes: ComplyFDA’s Insightful Approach to Baseline Assessments
Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to ensure robust solutions. I found this analysis extremely insightful and wanted to share it with you: Read more »
Elisa Kim, Mike Wallenstein, John “Barr” Weiner and Khaudeja Bano spoke at the Combination Products Summit. Source: Michele G. Sullivan
Insights From Combination Products Summit
The journey of developing and commercializing combination drug/device products is filled with challenges, primarily due to the non-harmonized global regulatory frameworks. As discussed at the recent 2023 Combination Products Summit, manufacturers face significant hurdles because different countries have their own definitions and requirements for these products. This lack of uniformity complicates the application process, adding layers of complexity and burdening manufacturers. Read more »
Celebrating 20 Years of Excellence and Innovation!
Twenty years ago, Quality Solutions Now (QSN) embarked on a mission to create a world where health is protected and promoted through the manufacturing of safe and effective medical products. From our humble beginnings in October 2004, QSN has seen tremendous growth, now serving a diverse range of clients in the medical device, drug, and biologic manufacturing sectors.
As we celebrate our 20th anniversary, we reflect on our journey and the remarkable milestones we’ve achieved. Here’s a look at our progress: Read more »
Quality Solutions Now and ComplyFDA Partnership
Leading the Way in Life Sciences Compliance and Quality Management
Quality Solutions Now (QSN) and ComplyFDA have joined forces to offer unparalleled solutions in quality management and regulatory compliance for the life sciences industry. This collaboration enhances our capabilities in providing comprehensive, scalable, and cost-effective solutions, ensuring clients meet and exceed quality and regulatory standards. Read more »
A risk-based approach to QMS. If you’re a manufacturer of medical devices, including the medical device portion of combination products this is not the first time you’ve encountered this emphasis; the shift towards Quality by Design (QbD) has placed risk assessment and management at the forefront of compliance and regulatory considerations for organizations operating within the life sciences industries. But ISO 13485:2016 and its quickly approaching requirements for certification have brought risk front and center for medical device manufacturers with a renewed urgency. Read more »
Business continuity planning (BCP) is essential for the success of any enterprise, but it’s particularly crucial for companies in the life sciences industries, where criticality and compliance with FDA regulations may be impacted by a host of factors ranging from cybercrime to natural disasters to disruptions in the supply chain. Read more »
For companies in the Life Sciences industry, today’s climate—a mixture of competition, regulation, increasing consumer awareness, and continually evolving knowledge and capabilities—presents manufacturers of pharmaceuticals, medical devices, biologics, and combination products with a choice: maintain the status quo in product design, manufacture, and testing, or join the forward motion of the industry as well as the FDA in embracing the holistic and dynamic approach of Quality by Design (QbD). Read more »
