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Parasoft Resources Center: FDA & Medical Devices

Agile Quality Practices that Save Time

This 12-page eBook aggregates 10 tips for ensuring that each new feature is truly "done"...and defects don't derail your Agile project. read more >>

The Case for Policy-Driven Development

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

IMA Case Study

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

The Case for Policy-Driven Development , April 2012

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

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White Paper
IMA Case Study , January 2012 - 477 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.

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Case Study
Static Analysis for FDA Software Validation Compliance eBook , July 2011

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.

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White Paper
Software Development Standards Compliance Solution , July 2011

Introduces the Compliance solution (for FDA, DO-178B, MISRA, JSF, PCI-DSS, ISO, IEC...), which ingrains compliance tasks across the SDLC & into the team workflow.

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Web Page
Static Analysis for FDA and Medical Device Development , July 2011

Introduces Parasoft's static analysis capabilties for FDA / IEC 62304 / medical device development.

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Web Page
FDA / Medical Device Software Development Solution , June 2011 - 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.

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Data Sheet
Inomed Case Study , May 2011 - 152 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.

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Case Study
Parasoft Support for IEC 62304 Medical Device Software Certification , May 2011 - 1,052 KB PDF

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

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White Paper
FDA and Medical Device Software Development Solution , February 2011

Introduces the FDA/Medical Device Development solution, which helps you uniformly apply the least burdensome practices to mitigate the safety risks associated with your medical device software.

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Web Page
FDA Software Validation Guidance eKit , December 2010

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

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Guide/Kit
FDA Software Validation Compliance , July 2010

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

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White Paper
MedicAlert Case Study , July 2009 - 100 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.

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Case Study
Bovie Medical Case Study , June 2009 - 162 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.

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Case Study
 
 
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