Operational Readiness and Health Checks
A launch and scale-up readiness assessment for IVD and medical device operations: a structured look at where your operation will break under new volume, a new site, or an investor’s questions, and what to fix first.
Book a 30-minute callWho it is for
- Diagnostics and medical device companies approaching commercial launch
- Companies scaling up volume or bringing a new site online
- Leadership teams facing an investor or acquirer review
- Operations that have grown quickly and no longer feel under control
This is an operations review, not a regulatory audit.
It looks at how planning, manufacturing, quality interfaces, supply chain, and systems work together day to day, and where the handoffs between them fail. If your question is IVDR or ISO 13485 compliance, a regulatory consultancy is the right first call; if it is “will our operation hold up,” this is.
Where value leaks
The assessment follows the work across each of these handoffs, because data details matter at every one.
What you receive
Readiness scorecard by function
Where each function stands today, scored on the same scale so you can compare.
Prioritized gap list with owners
What needs fixing, in order of risk, with a named owner for each item.
Remediation roadmap
A phased plan to close the gaps, plus assistance to source solutions where you want it.
Executive readout
A clear briefing for leadership or your board on what was found and what it will take.
How it works
- 01
Scope
Agree which functions, sites, and milestone the assessment is measured against.
- 02
On site
2 to 3 weeks working where the problems live, on the floor and in the data.
- 03
Analysis
Findings measured against a KPI framework and maturity scale.
- 04
Readout and roadmap
Findings, priorities, and a phased plan, handed over to your team.
Typical length8 to 12 weeks, of which 2 to 3 on site
Can run as a fixed-scope project or as part-time interim leadership alongside your team.
Recent result
Operational readiness assessment and S&OP standup
For a diagnostics company preparing to scale: a KPI framework, maturity scorecard, and gap analysis, turned into an 18-month phased implementation roadmap, plus support standing up its Sales & Operations Planning (S&OP) process.
Approaching launch, scale-up, or a review?
A 30-minute call is usually enough to tell whether an assessment is the right next step.