Medical Devices

Orig Group of People

Discover the range of services we offer to assure the quality, safety and usability of medical devices, from blood presure monitors and defibrillators, to walking aids and implants.

Find in-depth information in Consumer Compact, where you can read articles written by SGS experts and links to the relevant services across our website.

We test many products, here are just a few to discover. >

BandAid

Adhesive Bandages

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Defibrillator

Defibrillators

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Implant

Implants

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Adhesive Bandages

Makes no difference if it's cartoon-patterned or just skin color, it's for a small cut or a larger scar on the leg, if it happened falling off your bike or cooking your favorite meal, we offer a wide range of testing, technical assistance, inspection and consultancy services:

  • Product safety and performance testing, including:
    • Resistance to water penetration for primary wound dressings
    • Absorbency of primary dressings in contact with a wound
    • Water vapour permeability for dressings containing a permeable film
    • Flexibility of primary dressings in contact with a wound
    • Measuring linear adhesive strength of self-adhesive tape
    • Determining resistance to traction and stretching for non-woven dressings
    • Determining area density for non-woven dressings
    • Determining thickness of non-woven dressings
  • Technical assistance – expert assistance, every step of the way
  • Inspection and production control – product and packaging monitoring and quality control

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Defibrillators

Makes no difference if it’s to save one life or a thousand, if it’s in a hospital or in an ambulance, if it’s used by your doctor or a stranger, we offer a wide range of testing, technical assistance and inspection services:

  • Product safety and performance testing, including:
    • Safety according to EN 60601.1:2006+A1:2013 (basic safety) and EN 60601-2-4:2003 (cardiac defibrillator)
    • Software according to IEC 62304 series
    • Usability according to IEC 62366 series
    • Electromagnetic combability (EMC) according to EN 60601-1-2:2015
    • CB certification
    • Environmental testing
    • Transport testing
    • Life cycle testing
    • RoHS testing
  • Technical expertise – training
  • Regulatory services
    • EC Certification by a notified body for CE marking
    • Quality Management System Certification according to ISO 13485:2016
    • USA and Canada (NRTL) and International (MDSAP)
  • Sustainability services – IEC 60601-1-9 (Requirements for environmentally conscious design) testing

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Implants

Makes no difference if it’s brand new or 20 years old, if it’s for your hip or your hand, if you dance rock and roll or play golf, we offer a wide range of testing, technical assistance, inspection and consultancy services:

  • Product safety and performance testing, including:
    • Materials characterization
    • Chemical characterization
    • Cleanliness inspection (TOC, THC)
    • Mechanical and fatigue testing (traction, compression, flexion, resilience…)
    • Corrosion testing of implantable metals
    • Coating thickness
  • Technical assistance – expert assistance, every step of the way
  • Product and packaging monitoring and quality control:
    • Accelerated aging tests
    • Performance tests (seal strength, integrity, leaks tests, burst test…)
    • Transport simulation

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To find out more, visit our website.

www.sgs.com/medicaldevices