Processes Overview - Your Ideas Consulting

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.