Medical device certification relies on a higher level of documentation than most categories. It’s important — especially for start-up companies — to realize that a functional prototype is NOT sufficient to meet the full regulatory burden. This whitepaper outlines a few key reminders essential for any new device launch. Download the whitepaper now! […]
Whitepapers
See why the Q-Sub Program is key to regulatory strategy
The Q-Sub Program gives you pre-submission feedback straight from the FDA. It’s a simple way to streamline submission. If you have a medical device in development, take a look at how Avania can support you throughout the process. It Takes Avania. Read the White Paper.
Research Report: The Costly Impact of Ineffective Requirements Management
This report conducted by Axendia, a leading Life-Sciences Analyst firm, walks through groundbreaking research about the costly impact of ineffective requirements management in the medical device industry, including: The impact of ineffective closed-loop requirements management process. The importance of requirements to achieve better outcomes. The negative impact on budgets, traceability, V&V activities when relying on […]
For 40+ years, implantable medical textiles have played a pivotal role in the cardiovascular device industry.
Medical-grade textiles offer the versatility and performance that medical device OEMs seek to create implantable devices that best meet the needs of today’s applications. The incorporation of implantable textiles in vascular medical devices allows for increased flexibility and functionality in product design. Download BD Peripheral Intervention OEM’s white paper to learn more.
3D Printing: Making products better, faster, and more affordable
With help from HP’s Multi Jet Fusion 3D printing technology, Biotec produces improved parts for its medical devices in less time and at a lower cost. Download this white paper…
The Decentralized Hospital: Envisioning Our MedTech-fueled Future
The past year has also shown the urgent need to create robust, resilient, sustainable, interconnected health systems to address widespread challenges from high costs and provider burnout to our aging population and beyond. Star’s HealthTech Practice, in collaboration with Magic Leap, has crafted this focused look into the tech-fueled future of healthcare. Our experts assess […]
Advancing Life Science and Biomedical Manufacturing through Linear Motion: The OEM’s Guide
Life science and biomedical OEMs face tremendous pressures to achieve new advancements in technology, processes, workflows, and production. Discover how to realize critical improvements in capital equipment manufacturing — while ensuring against failures — with the proper utilization of next-generation linear motion systems. Announcing an exclusive new technical white paper for OEMs. Download this white […]
FDA Breakthrough Device Designation: What You Need to Know
The FDA Breakthrough Device Designation keeps you top of mind with the FDA, provides commercialization support, and gets attention from investors. For tips on how to apply, and how you can profit from breakthrough designation, get a copy of Avania’s latest white paper. Download the white paper from Avania to learn more…
How to Avoid the Top 8 Micro Design Mistakes
Nothing is more frustrating for micro medical part designers than to spend countless hours on a new drawing, only to get to the manufacturing phase and find out they need to make significant revisions or compromises. Download this white paper to learn how to improve the manufacturability of your next micro design.
Combatting Growing Cyber Threats Starts at the Top
Hospitals and other point-of-care healthcare environments are facing the enormous challenge of providing patients with the most innovative and advanced medical technologies, while also keeping all stakeholders safe from the growing number of cyber attacks that exploit device vulnerabilities. In response, healthcare facilities are putting much more scrutiny on medical device OEMs to demonstrate a […]
Vital Signs of the Medical Device Industry
The medical device industry is no stranger to change, but the COVID-19 pandemic has meant unprecedented levels of disruption across the board. Download “Vital Signs of the Medical Device Industry” to see what industry leaders have done in the face of upheaval and the new trends you can utilize to improve adaptability at your organization. […]
