Guiding & arranging certification for wearables
Arranging & guiding certification of wearables
Ensure your wearable technology meets global safety and compliance standards—efficiently and expertly.
With over 12 years of experience developing and testing wearables for the medical, sports, and military sectors, Elitac Wearables offers end-to-end support in certification and regulatory compliance.
Why certification matters
Whether you’re launching a smart textile, sensor-integrated garment, or haptic feedback system, certification is essential to ensure safety, reliability, and market readiness. We help you navigate complex regulatory landscapes, including:
- CE marking
- EMC testing
- Biocompatibility assessments
- Medical device classification
- Environmental and mechanical testing
What to expect
We guide you through every step of the certification process:
- Gap analysis & risk assessment
- Test planning and coordination
- Documentation and technical file preparation
- Liaison with notified bodies and test labs
- Post-certification support
Note that the actual certification is done by notified bodies.
In-house testing
Next to arranging and guiding external certification with notified bodies, we also have the facilities to execute lots of different tests in-house. Ranging from fucntional tests, signal quality to mechanical stress, impact and durability tests, including washing!
However, we do also execute pre-validation tests, especially for:
- Mechanical stress of hardware and textiles
- including stretch, fold and bend tests
- EMC pre-certification tests reducing risk, time and costs
- Durability tests
- Washability tests
Read more about what we can do for you with hardware testing here.
Proven track record
We’ve successfully guided certification for a wide range of wearables, including:
- Danu Sports – Smart insole for performance and injury prevention
- Mission Navigation Belt – Tactile navigation for soldiers in the field
- BalanceBelt – Medical device for patients with balance disorders
- SmartShoulder – Intelligent posture monitoring for industrial workers
Why choose Elitac Wearables?
12+ years of wearable development expertise
Deep knowledge of medical, defense, and industrial standards
In-house engineers, designers, and regulatory experts
Agile and collaborative approach
Contact us to explore how our hardware experts can support your development — from design to delivery.
EMC testing & Certification
Electromagnetic compatibility (EMC) isn’t just a regulatory hurdle — it’s critical to device reliability. We assist with pre-compliance testing and guide your wearable product through full EMC certification, helping you avoid costly delays or redesigns. Our deep experience with wearables means we know the common pitfalls — and how to avoid them.
