offers comprehensive support
Our team of experts offers comprehensive support for medical devices and AI or health-tech products throughout their entire lifecycle, including clinical, research, and medical affairs.
key points about our services
- Our team includes experts in a wide range of specialties and indications, including cardiology, neurology, oncology, and more. We can provide guidance and support for all types of medical devices, including Software as a Medical Device (SaMD), in vitro diagnostic (IVD) devices, and implantable devices.
- Whether you are developing a medical device or an AI or health-tech product, we can help you navigate the complex regulatory landscape. We have experience with a variety of regulatory requirements, including the Medical Device Regulations (UKCA, CE, FDA) and other standards for SaMD.
- Our team has extensive experience with clinical trial design and execution, and we can provide guidance on all aspects of the trial, including study design, patient recruitment, data collection and analysis, and safety monitoring. We can also help you navigate the complex regulatory landscape surrounding clinical trials, including requirements for informed consent, institutional review board (IRB) approval, and data privacy and protection.
test we support
| Test Services | Applicable Standards |
|---|---|
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SAFETY/EMC with CB Certification
|
IEC EN 60601 Series
|
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Usability
|
IEC 62366/60601-1-6
|
|
Wireless Testing
|
ETSI EN 301 489
|
|
Wireless Testing
|
ETSI EN 300 328
|
|
Wireless Testing
|
FCC- 47CFR Part 15 (ANSI C63.4)
|
|
Wireless Testing
|
FCC- 47CFR Part 15 (ANSI C63.10)
|
|
Wireless Coexistence Testing
|
ANSI C63.27
|
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Battery & Cell Compliance
|
IEC 62133, UN 38.3, BIS
|
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Environmental, Bump, and Vibration etc
|
|
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Biocompatibility
|
ISO 10933
|
|
SW life cycle procedure
|
IEC 62304, 82304
|
|
Penetration Test
|
NA
|