generativ Bildmarke png
Atlassian Platinum Solution Partner

Developing in compliance isn’t a burden—it’s your competitive edge.

Whether it’s medical devices, hospital IT, or digital health infrastructure—those who integrate requirements, risks, and evidence work more securely, pass audits without pulling all-nighters, and build trust. We bring your processes onto a unified, auditable platform—compliant with standards such as ISO 13485, MDR, and data protection regulations.
Schedule a Consultation

Digital Processes in Regulated Development

Does this sound familiar to you?

Scattered Documentation

Controls, approvals, and versions are scattered across email and file servers—which makes traceability and audits more difficult.

Lack of Traceability

Requirements, risks, implementation, testing, and verification are not consistently linked—the common thread only emerges in hindsight.

Regulated Software Development

Teams must deliver quickly while consistently integrating reviews, releases, decisions, and evidence—in accordance with IEC 62304 for medical software.

Changes & CAPA

Deviations and corrective actions require clear assessment, accountability, and tracking across teams and systems.

Suppliers & Partners

Supplier evaluations, qualifications, and documentation are scattered across Excel files and email inboxes.

Security, Data Protection & Audits

Sensitive health data, access logs, and documentation for ISO 13485, the MDR, or data protection must be verifiable at all times.
More tools won’t solve this. A consistent approach—from requirements through risk and testing to validation—will.

Faster Progress from Request to Verification

Development, risk, testing, and quality are seamlessly integrated.

Less manual coordination

Reviews, approvals, and actions take place as part of the process rather than in meetings or via email.

Mastering Change with Confidence

The impact on the product, risk, documentation, and evidence remains transparent.

Our Solutions for Healthcare and MedTech Companies

In three steps: understand, integrate the process, operate the system.

Assess

Healthcare / MedTech Checkup

Comprehensive assessment: strategic goals, process and tool landscape, maturity level, and prioritized use cases—including a target vision and roadmap—at a fixed price, completed in two to four weeks.

Assess

ISO 13485 & MDR Process Assessment

In-Depth Analysis: A Specific Regulatory Process Area in Detail—Process Coverage, Roles, Documentation, and Traceability, Including a Gap Analysis and Implementation Backlog.

Build

Risk Management Board
Requirements, implementation, and evidence linked together—including controlled documents and traceability that scales with your business.

Build

Biological Safety Assessment & Material Compliance
Biocompatibility and material compliance are managed in a traceable manner—evaluations and documentation in accordance with ISO 10993, linked to risk and design.

Build

IEC 62304 Software Workspace
Reviews, releases, decisions, and documentation all in one workflow—regulated yet fast, for medical software.

Build

Verification & Test Board
Tests, results, and approvals are clearly linked to requirements and supporting documentation—you can see immediately what has been tested.

Build

Change Control & CAPA
Deviations, causes, and effectiveness are tracked in a structured manner—with clear lines of responsibility.

Build

Complaints & Post-Market Process
Feedback from the market and operations is systematically linked to quality and development.

Build

Suppliers, Training, & Audit Records
Supplier evaluations, training records, and audit documentation—all traceable and stored in one place—readily available for ISO 13485 and MDR audits.

Run

generativ:care
If regulatory requirements or Atlassian Cloud change, we’ll ensure your workflows, templates, and documentation remain compliant—including an assessment of the Cloud changes and re-qualification.

Track Record

Experience in Healthcare, MedTech, and Digital Health

Our team brings together experience in regulated industries, quality management, and digital product development. We translate requirements from development, quality, and regulatory affairs into integrated processes on the Atlassian platform.
Processes for the Digital Health Infrastructure
Scaled Development in Healthcare
Swiss medtech manufacturer (anonymized)
Quality Management and Development Processes on Atlassian
Setup for the Integration of the Further Development of the Hospital Management System
Integrated product development and service processes, including CIRS (Telenotarzt – Digital Emergency Response Chain for Emergency Care)

Quality & Trust

Certified—and experienced where compliance matters

ISO 9001-certified, Atlassian Platinum Solution Partner—with experience in ISO 13485 and MDR environments.
Your Contact Person

Contact Person for Healthcare / MedTech

Tom Becking

Tom Becking

Senior Consultant - Business Solutions

Talk to us
Briefly described, quickly answered—we’ll get back to you with an initial assessment.

1 + 11 =

FAQ

Why is Atlassian suitable for regulated development?

Compliance becomes a competitive advantage: We integrate design control, risk management, and verification into interconnected workflows—the common thread emerges during the process itself, rather than during audit week.

Will Atlassian replace our QMS?

No—you don’t have to maintain a second QMS. We understand the distinction between eQMS and the work platform, and we start right where your teams work every day.

How does agile software development align with IEC 62304?

Your teams stay agile and provide the necessary documentation right away—reviews, releases, and decisions are carried out as part of the development process, within the structure required by the standard.

How does the platform support audits in accordance with ISO 13485 and the MDR?

Audit preparation without working late: Findings, corrective actions, and supporting documentation are linked—we know what auditors want to see, and we design our processes accordingly.

Can the platform be validated?

Yes—and it will remain that way. We’ll develop the validation plan and support the re-qualification process when Atlassian Cloud is released or your processes change.

How do you handle sensitive health information?

Access is controlled and verifiable—authorization policies and data residency in the EU and Switzerland, aligned with data protection and regulatory requirements.

How do development partners and suppliers collaborate?

No—hospitals, health insurance companies, and digital health infrastructure also benefit. Our projects range from device development to health IT.

How quickly do we become productive?

In weeks rather than months: An assessment of the current situation and a roadmap in two to four weeks, followed by a step-by-step approach—with support from generativ:care.

Why generative?

Because we bring together quality management, regulated development, and the Atlassian platform—in a pragmatic way and with experience in ISO 13485 and MDR environments.