While the medtech industry takes strides towards digital technologies, many still rely on manually intensive and time-consuming processes. Learn how Alcon and Terumo utilized digitization, redesigning their systems to increase efficiency, accelerate cross-functional procedures, and support continuous global regulatory compliance, including: ● Creating a Single Source of Truth Across Departments ● Integrating Risk Management into […]
Whitepapers
MDR Clinical Investigations
Clinical investigations must have specific strategies and practices to be successful. Understand how particular requirements for clinical investigations exist under the European Medical Device Regulation 2017/745 (MDR). Conducting a clinical investigation takes ample time and requires many resources from a medical device manufacturer. Manufacturers need a clear purpose for a clinical investigation. They should understand […]
MDCG Summary of Safety and Clinical Performance
Manufacturers navigate various challenges in meeting the regulatory requirements related to Class III and implantable devices. Learn about the Summary of Safety and Clinical Performance (SSCP), a European Medical Devices Regulation 2017/745 requirement for devices to meet performance, clinical, and safety standards related to the device’s purpose. Download full document below.
Clinical Evaluation Under EU-MDR
After the publication of Directive 2007/47/EC in 2007, manufacturers must follow additional and revised guidelines related to the technical documentation of clinic evaluations. Understand how the requirements affect the focus of clinical investigation and how manufacturers can understand the criteria operate in practice, specifically regarding clinical investigation scope and planning. Download full document below.
Preparing your medical device company for challenging market conditions
Recession. Inflation. Supply chain challenges. These are some of the headwinds facing medtech companies today. Through this industry report, we’ll explore strategic considerations for managing through and coming out on top. With so much out of your control, focus on what you can with supply chain, sales and marketing strategies. Download Now.
Complimentary whitepaper: “5 Essential Steps for Medical Device Certification”
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! […]
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 […]