Services
Engineering Consultancy
Regulatory roadmap, risk management, software life cycle and electrical safety pre-assessment; device selection and technical specifications for hospitals.
Consultancy in medical devices is less about producing documents and more about asking the right questions in the right order. Which market is targeted, which class does the device fall into, which evidence is missing? The answers define the roadmap; we draw that map with you and stay alongside during implementation.
Work starts with a gap analysis. We assess your current documents and processes against your target and prioritise the gaps. We then deliver a written roadmap with steps, responsibilities and a schedule. During implementation we prepare documents together and mature them through review and correction rounds.
For hospitals and clinical engineering units the focus differs: technical specifications for device selection, acceptance tests and knowledge transfer to the technical team. On both sides the principle is the same: written scope, traceable output and transparent communication.
What we do
- Regulatory roadmap based on product and target market
- Setting up and reviewing the risk management file
- Software life cycle processes and documentation
- Electrical safety pre-assessment and test laboratory readiness
- Supplier and manufacturer technical audit support
- Device selection, acceptance testing and technical specifications for hospitals
Process
-
Gap analysis
Existing documents and processes are assessed against the target; gaps are prioritised.
1–2 weeks -
Roadmap and proposal
Steps, responsibilities and schedule are presented in writing.
3–5 working days -
Implementation support
Preparing documents, joint reviews and correction rounds with your team.
Scope dependent -
Readiness check
Final checklist before submission or testing, plus a closing meeting.
1 week
What you receive
- Gap analysis report
- Written roadmap and schedule
- Reviewed document set
- Readiness checklist
Frequently asked questions
Can we get support for a single document only?
Do you talk to the notified body or test laboratory on our behalf?
What do you work on with hospitals?
Not sure which service fits?
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