Quality & compliance | Aprikos Medical
Quality & compliance

Certified. Documented. Verifiable.

Aprikos Medical is a Norwegian manufacturer of surgical instruments and medical furniture. Every product is designed, manufactured and released under a certified quality management system.

How we work

Quality is the product

For a surgical instrument there is no such thing as “good enough”. Our quality focus runs from design and manufacturing to post-market follow-up of every batch we release — and our Code of Conduct sets the same standard for how we do business as for what we make.

Patient safety first

Every decision is measured against one standard: safe use in the operating theatre. Vigilance, complaint handling and post-market surveillance under MDR 2017/745.

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Code of Conduct

Anti-corruption, fair competition, labour and human rights. Signed by every employee — and required of every manufacturing partner and supplier we work with.

Full traceability

Every product is traceable by article and batch, from raw material to delivered order — UDI-labelled in line with MDR requirements.

Environmental responsibility

ISO 14001-certified environmental management — responsible material choices, reduced packaging and lower-impact logistics across the supply chain.

Continuous improvement

Internal audits, CAPA and management review keep the quality system alive — a working tool in daily operations, not a binder on a shelf.

Certifications

Certificates & documentation

MDR 2017/745

8,000+ codes certified. Notified body NB XXXX.

ISO 13485:2016

Quality management for medical devices.

ISO 14001

Environmental management system.

CE marking

EU health, safety and performance conformity.

Multi-source manufacturing, one quality system

Manufacturing partners in Germany, Türkiye and Pakistan — every product qualified, quality-assured and released under our Norwegian ISO 13485 quality system.

Document vault — restricted access

Certificates, Declarations of Conformity, IFU and technical files are available to registered distributors, hospitals and tender officers.

Log in
DocumentTypeScopeValid toAccess
EC Certificate — MDR 2017/745PDFFull portfolio2030
ISO 13485:2016 certificatePDFDesign & manufacture2029
Declaration of Conformity — General SurgeryPDFClass I / Is
IFU & reprocessing instructionsPDFAll instruments
Tender documentation packZIPProcurement
Code of ConductPDFPublicOpen ↓
Certification summary (1 page)PDFPublicOpen ↓

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