software REGULATORY SERVICES

Promenade Software provides software regulatory 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 MDR/IVDR submission.

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Design history file (DHF)

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 21CFR Part 820, ISO 13485 and IEC 62304 compliant. We have templates for each document required, ensuring full compliance to the associated standards.

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 rejection.


Whether for a custom device or Software as a Medical Device (SaMD) , Promenade Software regulatory services can help you with your submission.

For more on SaMD  (Software as a Medical Device), refer to our SaMD specific blogpost.

design control

  • Software Development Plan - Lifecycle plan, including Configuration Management Plan, Risk Management Plan, Documentation Plan
  • Software Requirements -  complete, unambiguous, and verifiable software requirements
  • Software Architecture and Detailed Design

risk management

  • Software Hazard Analysis and traceability to the associated mitigations
  • COTS Reporting - Documentation and Hazard Analysis and Mitigations
  • Release history and unresolved anomalies report

CYBERSECURITY

  • Cybersecurity Design Documentation- Description of the cybersecurity design features and controls
  • Cybersecurity Risk Management - Threat Modeling and Risk Management
  • CBOM generation and post-market known vulnerability monitoring

Verification

  • Verification Plan - includes unit, integration, and system verification plans
  • Test Procedures - full test of the system software requirements
  • Traceability of software requirements and hazard mitigations to test procedure
Contact Us
16 Technology Drive, Suite 100
Irvine, CA. 92618, U.S.A.
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ABOUT
PROMENADE SOFTWARE

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and CyberMed • Cloud is SOC2 Type II certified.

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