EUROPEAN REGULATORY EXPERTISE
Your Trusted Partner in EU Medical Device Compliance
Experience the Power of Strategic Regulatory Partnership
At Osseous, we transform regulatory complexity into market opportunity. As your dedicated EU Authorized Representative, we provide comprehensive solutions for medical device manufacturers seeking to enter or expand in the European market.
At Osseous, we transform regulatory complexity into market opportunity. As your dedicated EU Authorized Representative, we provide comprehensive solutions for medical device manufacturers seeking to enter or expand in the European market.
Medical Industry
We guide manufacturers through the complete regulatory lifecycle of:
Medical Devices
Class I, IIa, IIb, and III devices
Active medical devices
Implantable devices
Software as Medical Device (SaMD)
Active medical devices
Implantable devices
Software as Medical Device (SaMD)
In-Vitro Diagnostics
Diagnostic instruments
Reagents and test kits
Calibrators and control materials
Software for diagnostic purposes
Reagents and test kits
Calibrators and control materials
Software for diagnostic purposes
Aesthetic Devices
Professional aesthetic equipment
Light-based devices
Energy-based devices
Minimally invasive devices
Light-based devices
Energy-based devices
Minimally invasive devices
EC REP Legal Framework
Navigate European regulations with confidence through our comprehensive understanding of:
- Medical Device Regulation (MDR 2017/745)
- In Vitro Diagnostic Regulation (IVDR 2017/746)
- Essential safety and performance requirements
- Conformity assessment procedures
- Post-market surveillance requirements
Contact us for a free consultation