Marissa Vilchez
Consultant
With over 30 years of experience, MDSS is a leading Authorized Representative and Regulatory Consulting organization, headquartered in Germany with offices in the United States, the United Kingdom, Switzerland, and Australia.
Our services include:
• European Authorized Representative (EC REP)
• UK Responsible Person (UKRP)
• Swiss Authorized Representative (CH-REP)
• U.S. Agent
• Australian Sponsor
• Other services (e.g. Free Sales Certificates, GDPR, GPSR, Representative for Clinical Investigations, Vigilance, …)
In addition to providing In-Country Representation services — helping streamline global market access through a single, reliable partner, so you can focus on your core business and innovation — we offer regulatory strategy consulting for medical devices and IVDs, support with pre-submissions and marketing authorization applications to the FDA, and assistance with EU MDR and EU IVDR compliance.
Why MDSS?
• 30+ years of regulatory expertise
• Same trusted address for 20+ years
• Personalized support and tailored approach that sets MDSS apart from other regulatory service providers
• Collaborative network of offices spanning from the USA to Australia – single verification that grants access to three key markets: the EU, the UK, and Switzerland
• Independent services that protect your intellectual property
• Full control of your technical product files—no need to share with local importers or distributors
MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).
For more detailed information, visit our website at www.mdss.com.
Our services include:
• European Authorized Representative (EC REP)
• UK Responsible Person (UKRP)
• Swiss Authorized Representative (CH-REP)
• U.S. Agent
• Australian Sponsor
• Other services (e.g. Free Sales Certificates, GDPR, GPSR, Representative for Clinical Investigations, Vigilance, …)
In addition to providing In-Country Representation services — helping streamline global market access through a single, reliable partner, so you can focus on your core business and innovation — we offer regulatory strategy consulting for medical devices and IVDs, support with pre-submissions and marketing authorization applications to the FDA, and assistance with EU MDR and EU IVDR compliance.
Why MDSS?
• 30+ years of regulatory expertise
• Same trusted address for 20+ years
• Personalized support and tailored approach that sets MDSS apart from other regulatory service providers
• Collaborative network of offices spanning from the USA to Australia – single verification that grants access to three key markets: the EU, the UK, and Switzerland
• Independent services that protect your intellectual property
• Full control of your technical product files—no need to share with local importers or distributors
MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).
For more detailed information, visit our website at www.mdss.com.
