Parasoft Resources Center: FDA & Medical Devices

Parasoft TV: Introducing C/C++test For Embedded Development

Learn how Parasoft C/C++test reduces the risks of safety-critical and embedded development by automating static analysis, peer code review, unit/component testing, traceability, coverage, and runtime error detection—on the host, simulator, or target.

FDA Software Validation Compliance   by Wayne Ariola (Chief Strategy Officer), Adam Trujillo (Technical Writer), Cynthia Dunlop (Lead Technical Writer)

Details how Parasoft supports FDA General Principles of Software Validation sections 3, 4, and 5.

Parasoft TV - FDA Compliance Static Analysis and Beyond

Learn how static analysis can be a key component of your strategy for FDA software validation.

The Case for Policy-Driven Development: Embedded Systems   by Wayne Ariola (Chief Strategy Officer), Adam Trujillo (Technical Writer)

Learn how policy-driven development can help businesses in the embedded systems space overcome the shortcomings of traditional software development.

IMA Case Study - 561 KB PDF

By working with Parasoft , IMA significantly increased the efficiency and auditability of the strict quality process they adopted to comply with pharmaceutical industry regulations.

Static Analysis for FDA Software Validation Compliance eBook   by Wayne Ariola (Chief Strategy Officer), Cynthia Dunlop (Lead Technical Writer)

To assist organizations that are exploring static analysis for FDA compliance, this 12-page guide describes Parasoft's static analysis capabilities in the context of FDA compliance.

FDA / Medical Device Software Development Solution - 101 KB PDF

This data sheet introduces Parasoft's pre-configured system with processes & best practices for FDA/medical device software compliance. It helps organizations uniformly apply the least burdensome practices to produce medical device software consistently & efficiently, with freedom from unacceptable risks.

Inomed Case Study - 568 KB PDF

Inomed wanted to streamline the risk management processes they established for IEC 62304 medical device software certification. Learn how they increased efficiency through automation—and also achieved full requirements traceability.

Parasoft Support for IEC 62304 Medical Device Software Certification - 1,052 KB PDF  by Marek Kucharski (President Parasoft SA, VP of Dev)

Find out how the Parasoft Compliance Solution helps organizations adopt practices for IEC 62304 compliance in the least burdensome manner.

FDA Software Validation Guidance eKit

Learn how one company cut compliance costs 50%— and get tips for your own compliance.

MedicAlert Case Study - 554 KB PDF

MedicAlert needed to accelerate its ability to roll out new services in a secure and effective fashion. Learn how they established a process for managing the functional, security, and performance testing challenges associated with their new capabilities and offerings.

Bovie Medical Case Study - 565 KB PDF

Bovie Medical had been using an outside vendor to perform the software validation required for FDA compliance, but they wanted to improve the effectiveness of testing while at the same time reduce testing costs. Learn how Parasoft helped them move verification and validation testing in-house—cutting costs approximately in half and getting to market 6 months sooner.