Design history lives in documents
Design history files are compiled by hand from spreadsheets and documents, so updating them after a change is slow.
Design controls your teams can work within.
Medical device development has to show how user needs became design inputs, how they were verified and how risk was controlled. That evidence is easier to maintain when it is produced inside the engineering workflow.
- Polarion
- Codebeamer
- Windchill
- Teamcenter
Where the thread usually breaks
Risk is disconnected from design
Risk analyses are maintained separately from requirements and tests, making the impact of a change hard to assess.
Device software adds another layer
Software development under IEC 62304 needs its own traceability alongside the hardware record.
What we focus on
- User needs, design inputs and verification linked in ALM
- Risk records connected to requirements and tests
- Controlled release and change workflows in PLM
- Traceability reports that support design history and audits
Relevant services
Product Lifecycle Management
Windchill and Teamcenter implementation, configuration, migration and enterprise integration.
Application Lifecycle Management
Codebeamer and Polarion workflows for requirements, development, verification and release decisions.
Consulting & Assessment
A practical review of engineering workflows, data and systems, followed by a prioritized implementation roadmap.
Delivery approach
How an engagement runs.
- 01
Discover
Workshops with engineering, IT and quality to map the current workflow and agree priorities.
- 02
Design
A target data model, integration architecture and scope with measurable acceptance criteria.
- 03
Build
Configuration and integration in short iterations, reviewed against representative records.
- 04
Validate
Migration reconciliation, integration tests and user acceptance before cutover.
- 05
Operate
Handover, administrator guidance and support while the new workflow settles in.