Global Medical Device Consultancy –
EU, UK, US & Swiss Compliance
Legal background
Compliance with medical and healthcare regulatory frameworks is not optional; it is mandatory to access the various regulated markets around the globe. Choosing the right consultancy partner ensures your devices remain compliant, competitive, and trusted, no matter where you sell them.
Without expert guidance, manufacturers risk:
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- Product recalls or market withdrawals
- Fines, enforcement actions, or customs detentions
- Delays in CE marking, UKCA marking, FDA clearance, or Swiss registration
- Loss of distributor, healthcare, and consumer trust
- Restricted access to new markets
Our services
How Obelis Supports Your Compliance Worldwide
At Obelis, we act as your global regulatory partner across the EU, UK, U.S., and Switzerland. Our services cover every stage of the compliance process: we review and prepare technical documentation, evaluate labels and claims, support with product registrations and national device notifications, and guide you through your necessary post-market access actions and obligations. We also assist with CE marking, UKCA marking, FDA submissions, and Swiss registrations, while monitoring regulatory changes that impact your products. Beyond consultancy, we offer tailored trainings and webinars to build your team’s knowledge and keep you prepared for evolving legislation. With Obelis, you gain a strategic partner that safeguards your compliance and accelerates your market access worldwide.
