Featured Resources

Balancing the Product Development Process

Before you switch to a new product development method or tool, make sure you're balancing development, regulatory and quality, and overall business needs. Learn how balancing these three functional areas will help you improve development speed, foster greater collaboration, and more nimbly respond to change.

Essential Traceability Components for Medical Device Development

As you design new medical products, multiple activities, changes, and requirements must be tracked, documented, and responded to by multiple stakeholders. Learn how an automated product development solution can trace every relationship and change, and provide instant visibility into data.

Recognizing the Danger Signs of Weak Traceability

Many organizations think their traceability practices are strong enough, but there are always areas for improvement. If your company or department exhibits any of the six symptoms discussed in this paper, your traceability may not be as strong as you think.

Six Exercises to Strengthen Traceability

Good traceability strategies and best practices help eliminate unforeseen issues and provide a greater assurance of quality and communication. Complete the exercises in this paper to learn where your traceability is weakest and how to strengthen it.

Impact of 21 CFR Part 11 on Product Development

This white paper will help you understand the impact of FDA ruling 21 CFR Part 11, and learn how good processes and the right product development management solution tool can help you achieve compliance.

Exposing Risk Throughout Your Product Development Lifecycle

Medical device development organizations must manage risks to the safety of patients and medical professionals, adding additional considerations to the process of managing requirements. Learn how traceability-based risk management practices can help you reduce the time spent assessing and managing risk, while supporting device approval.

Agile in FDA-Regulated Environments

At its core, Agile is a set of concepts and beliefs that stress flexibility and shared responsibility over rigid rules and formal processes. So, can Agile be used in an FDA-regulated environment? Yes. Read this white paper to learn how.

Transitioning to Agile in Safety-Critical Environments

To improve product quality, reduce production costs, and get to market faster, many organizations in safety-critical environments are exploring Agile. Read this white paper to learn about the challenges you may face, and how to overcome them and successfully transition to Agile.

2015 State of Medical Device Development Survey Results Analysis

Join Mike Brown, owner at Code Refinery, and Larry Nicholson, life sciences business development manager at Seapine, as they share real-world insight into the results of the 2015 State of Medical Device Development Survey.

How to Survive an Audit with Real-Time Traceability

Join Seapine life sciences solutions engineer, Michael Sieve, for a 45-minute webinar and learn how to prepare for and survive an audit. Michael will discuss how real-time traceability, gap analysis, and content reuse can help you make your product development process seamless, while enabling you to produce information for the FDA and international auditors at a moment's notice.

FDA Expectations for Traceability in Device and Diagnostic Design

Join us as John Avellanet, FDA and design compliance expert, provides best practices for incorporating traceability early, inexpensively, and compliantly in medical device development activities, clinical product development, and diagnostic software. You'll learn how you can avoid costly recalls and FDA enforcement by making your traceability practices more productive, without incurring expensive and time-consuming process overhead.

VirtualScopics Gains Enhanced Product Development Visibility

Clinical trials are used to determine if a new drug or medical device is safe and effective. These trials often generate several MRI, CT, ultrasound, and x-ray images, and it’s critical to the success of the trial that these images are analyzed and interpreted correctly. VirtualScopics implemented TestTrack to gain greater visibility into their product development lifecycle and improve their compliance efforts.

Anesthesia Division of Global Life Sciences Leader Reduces Overhead and Risk with Seapine’s TestTrack

Learn why this global life sciences leader chose TestTrack to help streamline the administration of the complex lifecycle of product tests.

Ximedica Brings Products to Market More Quickly With Seapine

Ximedica’s existing process for artifact submission was labor intensive and costly. With Seapine’s help, Ximedica created an integrated solution that allowed them to manage compliance artifacts and easily transfer management of that data to clients at the end of a project.