Start-up foundation
Move from founder-led practice to controlled development without importing a heavyweight corporate system.
Discuss this pathway →Solutions
Start with your business situation.
Most organisations do not need everything at once. These pathways combine the smallest useful set of processes for a recognisable development or assurance problem.
Buyer pathways
Different starting points. One connected system.
Use the pathways to frame the problem, then adjust scope for your device, markets, maturity and existing QMS.
Connected product
Integrate software lifecycle, cybersecurity, interoperability and organisational security.
Discuss this pathway →Audit or submission readiness
Identify missing processes and evidence, prioritise the gaps and establish visible readiness gates.
Discuss this pathway →Development recovery
Reconstruct a credible evidence chain when product development has moved faster than the controlled record.
Discuss this pathway →Established manufacturer
Strengthen a bounded process without destabilising the rest of a mature QMS.
Discuss this pathway →Consulting or partner use
Use a consistent licensed framework across client engagements, with white-label options discussed separately.
Discuss this pathway →Proposed bundles
Common combinations.
These bundles provide a practical starting framework. Final scope depends on the organisation, device portfolio, markets and existing QMS.
Development FoundationQMS Starter · Design Controls · Risk Management
Connected ProductSoftware Lifecycle · Cybersecurity · Interoperability
Safe UseRisk Management · Design Controls · Labelling & IFU
Market ReadinessClinical / Performance · Labelling · Gap Analysis
Lifecycle ControlQMS · ISQMS · CSA · Production Validation