Automate compliance activities for software as medical device development

CompliancePal augments GitHub functionality with workflows and document templates to keep your software development lifecycle compliant with ISO 13485 and ISO 62304.
compliance actions performed, and counting!

How it works

1. Documenting evolvable software

CompliancePal facilitates the process of documenting the software architecture, the decomposition of the software into systems, items and units without compromising speed or agility. The changes captured through decision records contribute valuable input for the risk classification activities.

2. Automatic SOUP detection

CompliancePal monitors newly developed software artifacts and detects automatically if 3rd party software components, known as software of unknown provenance (SOUP), are used. The changes cannot be merged until the compliance officer completes the risk management activities.

3. Development process enforcement

CompliancePal integrates with your version control system to monitor that the software is developed according to the team defined processes.

Compliance in sync with the development team

CompliancePal guides you to perform only the necessary regulatory activities during pull requests. Our workflows and document templates faciliate the collaboration between the development team and the compliance officer. The regulatory documentation is created when the change happens and the information is still fresh.

CompliancePal checks for updates

The developers and architects create new software artifacts and commit them to specific branches using the team established software development processes requied by ISO 13485

CompliancePal guides with task lists

If any changes require ISO 62304 regulatory actions, CompliancePal builds appropriate workflows with the contextual tasks delivered to the developers via commit statuses

You review and merge

The Compliance Officer checks the identified tasks, reviews the feedback, then approves the changes in the pull request. The new artifacts can be merged to the common base with confidence

Supported languages

CompliancePal performs automatic dependency management on software components developed with the following programing languages:

TypeScript
TypeScript
Python

Simplify regulatory compliance activities

Full visibility

View your software system, the decomposed components, and thier behaviour in one place

Efective decision making

Understand the context around each software asset to assist your compliance activities

Intuitive interface

All the power of CompliancePal behind a clean and easy to use user interface

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