Processes Overview - Your Ideas Consulting

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Processes Overview

Process Development

Process Development Overview

We support your Medical Device/ IVD product development processes with the following services:

  • Process analysis and proposal for improvements,

  • Responsible execution of the process within your project/ team: Set up, plan, report and tweak the process with its deliverables,

  • and Training

for the system development processes:

  • Requirements Management,

  • Product Risk Management,

  • Verification and Validation,

  • Product Configuration Management.

We apply a strong interdisciplinary perspective (hardware, software, reagents, disposables), which is accompanied by a mandatory adjustment:

  • to the complexity level of your product,

  • the linked regulatory strategy for your product,

  • as well as to specific needs of your organization/ departments.

Our activities and deliverables provided for one process will be matched with content elements, organization and documentation of the other there processes, e.g.:

  • Requirements Management Plan matching overall traceability including risk mitigation measures,

  • V&V document structure matching requirement documents levels,

  • Product configuration planned matching requirements changes, event driven risk assessment and respective re-validation effort, plan and reports.

It is critical to scale the process execution for an individual venture according to the required compliance level.

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