Who this is for
- Medical device teams preparing UKCA or CE evidence.
- Software-led companies that need a technical file without building an oversized compliance department.
- Founders who need to understand what assessors will actually review.
Services
Device regulation
Medical device compliance and technical evidence
UK MDR, EU MDR, technical documentation, clinical evaluation, post-market surveillance, UKCA and CE readiness.
UK MDREU MDRUKCA / CE
Service detail
Build the technical file, clinical evidence and post-market story assessors expect to see.
Typical client problems
- Technical documentation exists, but it does not tell one coherent regulatory story.
- Risk, clinical, software and post-market evidence are not connected.
- The team is unsure what must be completed now versus what can mature later.
What Neural Vibe does
- Creates or reviews the technical documentation structure.
- Connects risk, clinical evaluation, software lifecycle and post-market evidence.
- Prepares the team for assessment, audit or buyer review.
Deliverables
Practical outputs, not vague advice.
You leave knowing what is ready, what is weak, who owns it, and what will unlock NHS confidence.
01
File index
Technical documentation index
A structured technical file map that shows what exists, what is missing and how the evidence fits together.
Buyer value
Makes the regulatory story easier for assessors, auditors and buyers to navigate.
Neural Vibe does
We organise the file around claims, requirements, risk, software, clinical evidence and post-market obligations.
Technical fileClaimsRiskSoftwareClinical
- 01Structure
- 02Map
- 03Trace
- 04Control
Route
The pathway Neural Vibe manages.
Assess current documentation and target route.
Define the file structure and evidence gaps.
Build traceability from claims to evidence.
Prepare for assessment body or buyer scrutiny.
Standards and regulations
Frameworks this work can cover.
UK MDR 2002EU MDR 2017/745ISO 14971IEC 62304IEC 62366MDCG guidance
Start here
Let's turn this into your route to market.
Bring the product, the target markets and the questions. Neural Vibe will map the practical next step.
Book a discovery call