Your innovation is fueling medical device development, providing peace of mind to clinicians, patients and consumers. The key to achieving that level of confidence in your products is independent testing, assessment and certification.
At SGS, we help you bring medical devices to market safely and efficiently. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies.
We have full scope with more than 100 product categories, including:
Whatever your medical device, or target market, partner with us and we can help you ensure compliance to the appropriate mandatory quality and safety. Voluntary, brand and client specific standards can also be accommodated.
- Active medical devices
- Batteries and medical components
- Cardiac equipment
- Dental chairs & hospital beds
- Emergency medical devices
- Home healthcare devices
- Imaging equipment and surgical tools
- Implantable devices
- In vitro diagnostic devices (IVD) and laboratory equipment
- Medical PPE – gloves, masks, surgical gowns
- Packaging for medical products
- Software
- Syringes, medical tubing, needles
- Ultrasound devices
- Wheelchairs and walking aids
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Medical Devices Tested
Based in specialized laboratories around the world, our dedicated medical team has experience in testing:
- Biocompatibility
- Chemicals and materials
- Cybersecurity
- Eco-environment (hazardous substance analysis, life cycle analysis)
- Electrical safety
- Electromagnetic compatibility (EMC)
- Electromagnetic fields (EMF)
- Flammability testing
- Functional safety
- Mechanical and climatic
- Packaging
- Performance and reliability
- Sterilization
- Wireless connectivity
We have a wide portfolio of standards that we can test & certify to, including:
| Area of Competency | Sample of our Portfolio |
|---|---|
| Biocompatibility | ISO 10933 series, ISO 18562 |
| Electro-medical devices | IEC 60601 series, IEC 61010 series |
| Implantable medical devices | ISO 10933 series, EN 45502 series |
| Medical PPE | EN 455-1 & -2, ASTM F2407, ASTM F1670, ASTM F2100, EN 14683, EN 13795-1 |
| Packaging | ISO 11607, ASTM F1980, ASTM F1140, ASTM F1929, ASTM F1608, ASTM F88, ASTM F2096, ASTM F1980, ASTM D4169, ISO 11607-1, ISTA 3A |
| Sterilization | ISO 11137, ISO 11135, ISO 17665, ISO 11737, USP 85 |
| Surgical Tools | ASTM A967 |
| Syringes, medical tubing, needles | ISO 7886-1, ISO 594-1 |
| Wheelchairs and walking aids | ASTM D4169, EN 12183, EN 1986 |
Why choose SGS for your medical devices testing and certification?
We can advise and assist you in the production of the safest, most effective and technologically sophisticated products in the medical device industry. Our dedicated medical device division focuses on testing, certification and investigations.
When you choose to partner with SGS, you will not only gain access to a wealth of knowledge, but a partner that wants your innovations to succeed.
Megapark Business Centre, Floor 6, Office C, 115G Tsarigradsko Shosse Blvd.,
1784,
Sofia, Bulgaria