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Nordic MedTech AB

Gothenburg, Västra Götaland, Sweden · 120 employees · Founded 2011

Healthcare & Pharma

https://nordic-medtech.example.com

Swedish medical device contract manufacturer specializing in cleanroom assembly, sterilization, and regulatory-compliant packaging. Serves orthopedic, cardiovascular, and diagnostic device OEMs across Europe.

Certifications

ISO 13485:2016Verified

Issued by BSI

CE Marking (MDR 2017/745)Verified

Issued by BSI

FDA 21 CFR 820 RegisteredVerified

Issued by FDA

ISO 14644 Cleanroom Class 7Verified

Issued by SP Technical Research

Capabilities

Cleanroom AssemblyManufacturing Process

ISO Class 7 cleanroom for medical device assembly and packaging

EtO & Gamma SterilizationManufacturing Process

Ethylene oxide and gamma radiation sterilization with full validation

Biocompatibility TestingTesting & QC

ISO 10993 biocompatibility testing coordination and documentation

Regulatory DocumentationDesign & Engineering

Technical files, DHF, DMR, risk management per ISO 14971

Production Capacity

Min Order Qty
50
Lead Time
28 days
Production Lines
4
Annual Capacity
500K device assemblies/year
Shift Pattern
2 shifts, 5 days/week

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get_company_context({ slug: "nordic-medtech-ab" })

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