01
MDR opportunity qualification
Organize device, class, code, current-status and scope information for fit review.
- Qualification record
- Missing-information list
- Likely service pathway
- Partner-routing recommendation
EU certification support
Qualify the device and certification need before routing the work.
USHSG can organize the manufacturer, device, class, current status and requested service so an appropriately qualified certification resource can evaluate fit. Formal certification, conformity assessment, audit and testing decisions remain with the responsible qualified organization.
Initial qualification
Match the device and requested service to a provider whose designation and scope fit the work.
Qualification is intended to prevent time being spent on opportunities that are commercially interesting but outside the actual certification or technical scope of a partner.
Information for initial review
- Manufacturer, device and intended use
- Likely EU MDR device class and relevant code
- Current CE / Notified Body status
- Current ISO 13485 status
- Initial certification, renewal, extension, transfer or testing need
- Timeline, geography and decision owner
Support work
Qualification, coordination and documented follow-up.
02
Certification / renewal / extension coordination
Coordinate introductions, scope clarification, information flow and follow-up for a qualified opportunity.
- Opportunity brief
- Scope and document checklist
- Partner coordination
- Commercial next-step tracking
03
Transfer & testing coordination
Clarify whether the request involves transfer, testing or another specialized certification workstream.
- Current-status summary
- Requested testing / transfer scope
- Qualified-partner routing
- Open-issue tracker
04
ISO 13485 need qualification
Define whether the manufacturer needs initial QMS certification, renewal, expansion or related support.
- QMS status summary
- Certification need definition
- Scope information for provider
- Next-step coordination
ECM relationship.
Ente Certificazione Macchine (ECM) may be considered where its designation, scope and capabilities fit the device and requested work. USHSG does not represent ECM’s certification authority or technical decisions as its own.
Certification qualification
Have a device or manufacturer that may fit?
Send the device type, class, current certification status, requested service and timeline.