ISO certification for health & medtech in Northern Europe.
Patient data, device quality and strict EU regulation. We build the QMS and ISMS, write the technical documentation and prepare the audit — so you can focus on care and innovation.
💎 What certification gives a health organisation.
Market access, patient trust, and a regulatory system that holds up under inspection.
🏥 Market access
ISO 13485 is the QMS backbone of MDR and IVDR conformity. Without it, CE marking and EU market access stall.
🛡️ Health-data trust
ISO 27001 proves patient and clinical data are protected — a must for GDPR health-data duties and hospital partnerships.
❤️ Patient safety, systematised
Risk management, design controls and post-market surveillance embedded in a single auditable system.
🏢 Hospital & pharma partnerships
Hospitals, pharma and public-health buyers increasingly require certified QMS and security before any pilot or tender.
📈 Fewer audit surprises
Internal audits and mock inspections surface gaps early, so the notified body or certification audit is predictable.
🔐 Regulatory resilience
A documented, certified system makes it easier to respond to regulators, notified bodies and customer audits.
🎯 Who it is for.
Any organisation that touches patient data, medical devices or clinical quality — from startups to hospitals.
six health sectors where the certificate pays for itself ↓
Medical device manufacturers
MDR/IVDR requires a full QMS. ISO 13485 is the practical route to technical documentation and CE marking.
Digital health & SaMD
Software as a Medical Device needs both cybersecurity and quality controls. ISO 13485 + ISO 27001 covers both.
Hospitals & care providers
Patient data, availability and clinical governance are under constant scrutiny. Certification demonstrates systematic control.
Pharma & diagnostics
GxP expectations, data integrity and supplier qualification all benefit from an ISO-certified QMS and ISMS.
Healthtech vendors
If you process health data or sell into healthcare, buyers ask for ISO 27001 and often ISO 13485 or ISO 9001.
Labs & biobanks
Sensitive samples, research data and privacy rules demand traceability and access control. ISO 27001 and ISO 9001 provide the structure.
How it works
We prepare everything. You show up for the audit.
Doing ISO 13485 + ISO/IEC 27001 alone means months of reading the standard, writing documents, interpreting requirements and collecting evidence. We do the heavy part; your team only approves decisions and attends the audit.
Doing it alone
- Learn the standard and decide how each clause applies to you
- Write every policy, procedure and record from scratch
- Figure out which evidence the auditor will actually accept
- Run internal audits and management reviews yourself
- Coordinate the certification body and fix gaps under pressure
With Amprovia
- We scope the project and translate the standard to your operation
- We write every document around your real processes
- We collect and organise evidence so it is audit-ready
- We run internal audits, reviews and a realistic mock audit
- We coordinate the accredited body and prepare you for both stages
📄 Documents, evidence & audit prep — all in one place.
No scattered drives, no version chaos. We build, version and keep current every document the auditor needs, linked to the right evidence.
Book a free gap analysis🗂️ Your QMS & ISMS documentation, handled.
Everything inside the marked area is written, versioned and kept current by Amprovia.
📄 Documentation managed by us
Policies, procedures, records and revision history — drafted, approved and kept current by our team.
📊 Data managed by us
Evidence, KPIs and control checks collected on a schedule so nothing is reconstructed the week before the audit.
🤝 On your own, or with us.
The same certificate. A very different amount of work on your side.
🚀 Start with a free gap analysis.
One call, a look at your quality and IT systems, and a written read on scope, timeline and effort for your health or medtech certification. No commitment.
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