Requirements & Certification Check
Requirements & Certification check
Before launching your product, it’s crucial to ensure it complies with all relevant regulations and certifications.
But did you know, that passing regulatory certification starts at the beginning of your product development? Choosing the right intended use (what you claim), technology, materials, etc. can save you time and costs later on!
Our Requirements & Certification Check guides you through the complex landscape of standards for wearable technology—whether you’re developing a medical-grade device or a consumer wearable.
We help you identify and navigate:
CE marking for European market access
FDA requirements for U.S. medical devices
EMC (Electromagnetic Compatibility) standards
ISO 10993 & Biocompatibility guidance for textiles and skin-contact materials
Other relevant certifications and legal frameworks
Costs & Benefits
You’ll walk away with:
- A tailored cost breakdown
- A realistic development timeline
- Strategic advice on suppliers, materials, and technologies
- A roadmap that helps you move forward with clarity and confidence
€2.500
For 16 hours time and effort of one or more of our wearable experts!
This service is often part of our Wearables Brainstorm & Workshop, where we work hands-on with you to explore your concept, create a functional mock-up, and deliver a detailed development plan—including estimated costs and timelines.
Contact us
If you would like to learn more about our Starter services for wearable development, book a meeting with Selma with the scheduling tool.
She can help you choose the best Starter service for your development needs, and will match you with the right expert of our Elitac Wearables Team.
Hope to talk to you soon!
Interested in full service product development?