Who this is for
- Startups preparing for ISO 13485 or enterprise buyer assurance.
- Software teams that need quality controls without heavyweight paper systems.
- AI health companies connecting quality, security and AI governance.
Services
Management systems
ISO systems for regulated health technology
Lean, audit-ready systems for ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001 and ISO 42001.
ISO 13485ISO 27001ISO 42001
Service detail
Create a quality and assurance backbone that supports delivery rather than slowing it down.
Typical client problems
- Procedures exist, but teams do not actually use them.
- Software release, risk, supplier and design controls are inconsistent.
- Certification preparation is happening too late or in isolation from product delivery.
What Neural Vibe does
- Designs a lean system around how the team actually builds and releases product.
- Connects quality, risk, software, usability, security and AI controls.
- Prepares teams for certification, audits and buyer due diligence.
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
System design
QMS or integrated management system design
A management system shaped around how the team actually builds, releases, supports and improves regulated products.
Buyer value
Shows buyers and auditors that assurance is embedded in the business rather than sitting in a detached policy folder.
Neural Vibe does
We design the system architecture, process ownership, governance rhythm and evidence model across the relevant ISO standards.
QMSISMSAIMSPIMSEMS
- 01Scope
- 02Design
- 03Operate
- 04Improve
Route
The pathway Neural Vibe manages.
Define the certification and assurance goals.
Map current controls and product workflow.
Build lean procedures and evidence templates.
Prepare for internal audit, certification or buyer review.
Standards and regulations
Frameworks this work can cover.
ISO 13485ISO 14971IEC 62304IEC 62366ISO 27001ISO 42001
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