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Medical Device PM 2026 | FDA IEC 62304 ISO 14971

Medical device software development ships 40% faster with FDA compliance. IEC 62304 lifecycle, ISO 14971 risk management, 510(k) submission tracking. Free trial.

Medical Device PM 2026 | FDA IEC 62304 ISO 14971

Medical device software teams develop firmware and applications for diagnostic equipment, therapeutic devices, and patient monitoring systems.

Operating under IEC 62304 and FDA guidance requires risk-based development processes, formal requirements traceability, and extensive verification and validation activities throughout the software lifecycle.

The GitScrum Advantage

One unified platform to eliminate context switching and recover productive hours.

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challenges.identify()

Challenges

IEC 62304 software lifecycle compliance

Risk management integration per ISO 14971

Requirements traceability matrices

Long certification timelines affecting release planning

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solution.implement()

How GitScrum Helps

User stories link to software requirements specifications

Boards organize work by safety classification level

Wiki documents design history files and risk assessments

Git integration traces code changes to requirements

Sprint planning accounts for verification activities

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useCases.list()

Use Cases

Managing firmware development for diagnostic devices

Tracking software requirements per IEC 62304

Documenting design history files

Coordinating hardware-software integration testing

Planning 510(k) submission activities

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Why GitScrum

GitScrum provides Kanban boards, sprint planning with burndown charts, and workflow automation for Medical Device Software teams

Project management based on Scrum Guide (Schwaber and Sutherland) and Kanban Method (David Anderson)

Capabilities

  • Kanban boards with customizable columns and WIP limits
  • Sprint planning with burndown and burnup charts
  • Time tracking with billable rates
  • Wiki for documentation
  • Git integration for code linkage
  • Client Portal for stakeholder visibility

Industry Practices

Scrum FrameworkKanban MethodAgile Project ManagementContinuous Improvement
features.related()

Key Features

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Visual project management that actually fits how {vertical} work. Create unlimited Kanban boards with custom columns—from 'Client Review' to 'Ready to Deploy'—and set WIP limits that prevent the bottlenecks {city} teams know too well. Every card, comment, and status change syncs instantly across devices, so whether your {vertical} team is in the office or remote across {city}, everyone sees the same real-time picture.

Ship faster without the chaos. Drag-and-drop backlog prioritization, velocity tracking across iterations, and burndown charts that update as work gets done—not when someone remembers to update a spreadsheet. Your team always knows what's next, stakeholders see progress without asking, and {vertical} across {city} consistently hit their sprint commitments.

Code and project management finally speak the same language. Connect GitHub, GitLab, or Bitbucket in two clicks—every commit, branch, and pull request automatically links to the right task. Developers in {city} push code and managers see progress instantly, no status meetings required. {vertical} teams ship faster when the code tells the whole story.

Junior devs shouldn't access client billing. Contractors shouldn't see other projects. Set granular permissions that match how {vertical} actually work—by role, project, or even specific boards. Invite freelancers in {city} with time-limited access, track who did what, and revoke credentials in one click.

{vertical} make hundreds of decisions weekly—and most get lost in chat noise. Threaded discussions keep conversations attached to the work they reference. Tag teammates, attach files, and search past decisions instantly. When clients in {city} ask 'why did we do it this way?'—you'll have the receipts.

New hires asking the same questions. Process docs scattered across Google Docs, Notion, and Slack pins. Sound familiar? Build your team's single source of truth with rich text editing, nested pages, and instant search. {vertical} in {city} onboard new members 3x faster when everything is documented once and findable forever.

Frequently Asked Questions

Still have questions? Contact us at customer.service@gitscrum.com

How do we maintain requirements traceability?

User stories serve as software requirements. Git integration links code to stories. Wiki documents traceability matrices for audits.

Can we track by safety classification?

Labels categorize work by IEC 62304 safety class (A, B, C). Boards filter by classification. Different review processes for each class.

How do we document risk management?

Wiki stores risk assessments and mitigation strategies. User stories link to identified risks. Sprint reviews include risk evaluation.

Can we coordinate with hardware teams?

Shared boards with hardware dependencies clearly marked. Discussions facilitate cross-discipline communication. Milestones align hardware-software integration.

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