Regulatory and QMS health checks
An independent view of where you stand, what matters and what to address first.
Explore the serviceService 07
Post-market surveillance and vigilance readiness
A practical review of whether post-market processes, responsibilities and evidence connect.
Discuss your requirementsBring the current position into view.
Clearline helps review the agreed PMS and vigilance framework, clarify responsibilities and identify gaps between documented arrangements and operational practice.
Support may include
- Process and responsibility review
- Review of relevant inputs and records
- Escalation and decision-path observations
- Gap and improvement priorities
- Targeted implementation support
What this is intended to create
- Clearer ownership and escalation routes
- Better connection between evidence and action
- A proportionate improvement plan
Who this is suited to
Medical device SMEs that need to strengthen the practical operation of their post-market and vigilance arrangements.
The exact scope depends on the device, market, QMS maturity, available evidence and the outcome you need.
Connected support
Related services
A practical first conversation
Start with the situation as it is.
Tell us what is happening, what has changed and where you need clarity. We will consider whether Clearline is the right fit and suggest a sensible next step.
Discuss your requirements