Medical device companies face a unique challenge when they want to study their product performance post launch – a significant lack of detailed data on use of their device in clinical practice and the related outcomes. Understanding clinical outcomes or adverse events postmarket can be particularly challenging to piece together based on inadequate real-world data […]
Medical devices must comply with home healthcare safety and performance standards
Medical device manufacturers must consider the differences between a device used in a professional setting versus one used in the home. The users, environments and risks are quite different. This paper explores those variations and how testing helps you comply and capitalize on the fast-growing home healthcare opportunity. Please complete the form below to download […]
Lithium Ion Cycling Charge and Discharge
In this new report, we explore the cycling and performance characteristics of various-sized batteries under different conditions and highlight the performance of Resonetics lithium ion cells manufactured for implantable medical applications. Read now via the form below.
Regulatory Transformation Demands New Business Cases and KPIs
Medical device regulations continue to grow more complicated. For regulatory affairs departments to manage the ongoing challenges in workloads and regulator expectations, organizations are going to have to start planning for change. Learn Cook Medical’s and Exact Sciences’ top suggestions for tackling regulatory challenges and igniting changes needed within your organization, including: How to build […]
Enhancing Supplier Quality Management During Constant Change
Supply chain disruptions now require medtech manufacturers to use more resources to source new suppliers and manage quality control. Learn how Boston Scientific is maximizing their product distribution, ensuring quality control, and minimizing costs, including: Changes in technology that help manufacturers to innovate Impact of organizational change management Strategies for implementation that save time Download […]
Avania Analytics Platform Bypasses Unstable Internet
No connection? No problem! A research team was looking to utilize a real-time EDC system inside ORs and ICUs with little to no internet access. It takes practical insight, a custom-designed database, and an innovative eCRF to build a seamless solution. It Takes Avania. View the Case Study via the form below.
Alcon & Terumo: Rethinking Operating Models to Increase Regulatory Compliance
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 […]
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). This document details conducting a clinical investigation including the medical device manufacturer required resources. Download full document below.
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.