Our Services

Market Access

Regulatory Outsourcing

MDSAP audits FDA inspections CAPA Information Security

Strategic and Business Planning

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

EU, UK & Swiss Authorized Representative

Manufacturers without a registered office in EU country, Switzerland, or the UK must appoint a local representative. RASC offers such a service. Furthermore, we will consult your product compliance with local regulations and assist with product registration and market surveillance. We can also assist with product import to the selected countries.

Reimbursement Pathways

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Regulatory Strategy and Development Planning

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Partnering and Licensing

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Product Certification

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Product Registration

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales.

Product Compliance Consultations

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Quality Management System

MDSAP audits Surveillance audits

Information Security

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Vestibulum lacinia quam elementum nisl pellentesque sodales. Aliquam consequat quam at lorem sodales, vel ornare diam placerat. Aliquam commodo scelerisque odio, non egestas quam.

Surveillance & Certification Audits

MDSAP audits FDA inspections CAPA

CAPA

CAPA

Wireless Connectivity

Many modern medical devices use Bluetooth, Wi-Fi, LTE, or other wireless technology. Manufacturers are not aware that medical products must comply with FCC, RED, ANATEL, and other applicable requirements. We can support your team in obtaining the required proof of compliance.