professional  services

Software Verification and Validation (V&V)

Promenade Software provides  Software Test and V&V services for Medical Devices. We have years of expertise in FDA and IEC 62304 regulatory submissions, and can help you get through your 510(k), PMA, or CE submission.

Promenade software test experts will handle the software validation for your instrument.  As needed for your FDA submission, our test team will create your software Validation Plan, generate robust Test Cases against your requirements, execute testing, and provide the resultant Test Report and Trace Matrix.  

Promenade test services are specially tailored to your device. We develop innovative test strategies to make sure all aspects are covered. We start with the Risk Analysis to understand the the safety critical aspects of your devices to prioritize your testing. Then, from unit test, to system test, we go much further than basic requirements to ensure your device is ready for market. We engineer the test, to verify the performance, functionality, and user experience under good and bad conditions.

Our testing exercises the system software in ways not normally accessible by a user. With Parlay, and Phil, our Hardware in the Loop Test system, we can provide you with low-level test automation, including fault insertion, internal data monitoring and robust component testing.  Our testing fully characterizes your system under normal and stress use to ensure your system is able to gracefully handle unexpected situations.

Our testing is tough on your system in the lab, so you can be confident that surprises will not occur in the field.

Using Promenade's Hardware in the Loop Test System we can provide automated tests that monitor, log, and graph the behavior of your system, as measured from the electronics directly. Our test system can be wired up to your electronics for a full evaluation of inputs and outputs. We can measure pretty much everything going on in your system, without the need for special electronics, LabView, or other expensive packages. Test scripts are in read-able Python, and outputs are logs and graphs for easy, reproducible verification of requirements.

Regulatory Services

Promenade Software provides the full suite of software documentation necessary for your IDE, 510(k), PMA, CE  submission, as part of our development services. Our controlled processes are fully FDA and IEC 62304 compliant.

If you are doing your own development, our experts can guide you on the software portions of the design history file (DHF) . Or, if you have your DHF, we provide audit services, helping you avoid a costly denial.

Below are some of services provided

Design Control
  • Software Development Plan - Lifecycle plan, including configuration Management plan, Risk Management plan, Documentation plan...
  • Software Requirements - We will help you define and write complete, unambiguous, and verifiable requirements
  • Software Architecture and Design
Risk Management File
  • Software Hazard analysis and traceability to the associated mitigations
  • COTS Reporting - Documentation and Hazard Analysis and Mitigations
  • Cybersecurity - Hazard Analysis, mitigations, and design considerations, including list and justification for the controls established, and traceability to risks considered.
Software V&V
  • Software V&V Plan
  • Test Cases and Traceability to Requirements
  • Test Report


Whether you are doing development with us, or just need help with your submission, let our software regulatory expertise help you navigate through the regulatory process.

About Promenade Software

Promenade Software, Inc. specializes in software development for Medical Devices and other safety-critical applications.

Contact

Promenade Software, Inc.
16 Technology Drive,  Suite 100
Irvine, CA 92618 
U.S.A.
info@promenadesoftware.com
(949) 329-8570
Go to Contact Form

© 2016 Promenade Software, Inc.