I adapt to your context for one-off
or ongoing missions,
with several options
Flexible mission formats,
tailored to your needs
Guide-U2 can support your organisation through short-term projects, strategic advice, operational involvement or audit-related missions. The format depends on your objectives, your internal resources and the level of support you need
One-off project
Short-term
missions (audits, technical file reviews, GAP analysis) billed at a daily or
hourly rate, either on-site or remote
Strategic advice
Decision-making support (classification, notified body strategy, EUDAMED) primarily billed hourly
Operational support
Document
drafting, QMS implementation, CAPA, PMS on a project fixed time or part-time
basis
Audits
Internal/external
audits, suppliers, inspections with on-site visits and detailed reports
Your Benefits
Total flexibility: I work remotely or on-site. Tailored pricing: Daily rate for structured projects; hourly for advice
Typical situations I can help with
- Audit
- Support to demonstrate compliance
- Resolve regulatory and quality issues
- Transform QMS into strategic tools
- PRRC “Person Responsible for Regulatory Compliance” role
- Address regulatory constraints to master product market fit outcomes
Not sure which mission format fits your needs ?
Let’s discuss your context, your priorities and the type of support that would be most useful for your organisation.
What this can improve ?
- More consistent processes
- Better traceability and accountability
- Stronger audit readiness
- Clearer responsibilities and documentation
- A quality system that supports performance, not just compliance