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For organizations managing multiple products, projects, or broader RA/QA teams. Navigation provides the highest level of access, with regular touch points that keep leaders and their teams moving forward across several initiatives at once.
What’s Included:
Four to six advisor sessions each month (~180 minutes total)
Priority response for leaders and teams (typically within one business day)
Flexibility to shift focus between projects, submissions, audits, or strategy discussions as priorities evolve
Use Cases:
A company is pushing a 510(k), an MDR Technical Documentation update, and an MDSAP surveillance audit all within the same quarter. The RA/QA leader needs frequent outside perspective to keep resources aligned and prevent critical details from slipping.
A VP is covering three regions (U.S., EU, and Canada) while onboarding new team members. Regular calls provide a sounding board for high-level decisions while also helping junior staff get up to speed without slowing projects down.
Executive leadership decides mid-year to prioritize a U.S. De Novo over a CE Mark expansion. The RA/QA team needs to pivot quickly and weigh the downstream impacts on PMS, labeling, and supplier readiness.
A manufacturer receives multiple nonconformities across different sites. The RA/QA head wants to use recurring discussions to track responses, verify corrective actions, and keep progress visible at the leadership level.
Service Fee: $1200.00 per month
For organizations managing multiple products, projects, or broader RA/QA teams. Navigation provides the highest level of access, with regular touch points that keep leaders and their teams moving forward across several initiatives at once.
What’s Included:
Four to six advisor sessions each month (~180 minutes total)
Priority response for leaders and teams (typically within one business day)
Flexibility to shift focus between projects, submissions, audits, or strategy discussions as priorities evolve
Use Cases:
A company is pushing a 510(k), an MDR Technical Documentation update, and an MDSAP surveillance audit all within the same quarter. The RA/QA leader needs frequent outside perspective to keep resources aligned and prevent critical details from slipping.
A VP is covering three regions (U.S., EU, and Canada) while onboarding new team members. Regular calls provide a sounding board for high-level decisions while also helping junior staff get up to speed without slowing projects down.
Executive leadership decides mid-year to prioritize a U.S. De Novo over a CE Mark expansion. The RA/QA team needs to pivot quickly and weigh the downstream impacts on PMS, labeling, and supplier readiness.
A manufacturer receives multiple nonconformities across different sites. The RA/QA head wants to use recurring discussions to track responses, verify corrective actions, and keep progress visible at the leadership level.
Service Fee: $1200.00 per month