MDSS
MDSS provides expert regulatory representation and compliance services for medical device and IVD manufacturers globally. They specialize in EU Authorized Representation, FDA U.S. Agent services, and QMSR compliance.
MDSS is a seasoned provider of regulatory representation and compliance solutions, with over 30 years of experience assisting medical device and IVD manufacturers. They offer comprehensive In-Country Representation services across key global markets including the EU, UK, Switzerland, USA, and Australia. For the US market, MDSS acts as an official FDA U.S. Agent, serving as a crucial liaison for non-U.S. manufacturers to ensure compliance with FDA regulations and facilitate seamless market access. They also provide expert guidance on the FDA's Quality Management System Regulation (QMSR), helping companies navigate the transition to ISO 13485:2016. MDSS is dedicated to simplifying complex regulatory landscapes, allowing clients to focus on innovation and core business operations. Their services are designed to minimize risk, avoid costly delays, and ensure adherence to international standards.
About
**Who they are**
MDSS provides expert regulatory representation and compliance services for medical device and IVD manufacturers globally. With 30 years of global regulatory experience, MDSS acts as a trusted liaison with regulatory bodies.
**Expertise & scope**
* FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, serving as a communication link with the FDA.
* EU Authorized Representation, including services for GPSR and GDPR.
* UK Responsible Person services.
* QMSR compliance support, aligning with ISO 13485:2016.
* Representation to European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Services extend to Australia and Switzerland.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (EAAR).
* Member of the UK Responsible Person Association (UKRPA).
* Member of Swiss Medtech.
* Member of the Medical Technology Association of Australia (MTAA).
* Offers cost-effective solutions for regulatory obligations.
MDSS provides expert regulatory representation and compliance services for medical device and IVD manufacturers globally. With 30 years of global regulatory experience, MDSS acts as a trusted liaison with regulatory bodies.
**Expertise & scope**
* FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, serving as a communication link with the FDA.
* EU Authorized Representation, including services for GPSR and GDPR.
* UK Responsible Person services.
* QMSR compliance support, aligning with ISO 13485:2016.
* Representation to European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Services extend to Australia and Switzerland.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (EAAR).
* Member of the UK Responsible Person Association (UKRPA).
* Member of Swiss Medtech.
* Member of the Medical Technology Association of Australia (MTAA).
* Offers cost-effective solutions for regulatory obligations.
Additional information
MDSS specializes in simplifying market access for foreign manufacturers. Their FDA U.S. Agent service is a legal requirement for non-U.S. companies registered with the FDA, acting as a crucial communication channel. They also offer comprehensive support for EU Authorized Representation and UK Responsible Person roles. For QMSR compliance, MDSS assists manufacturers in navigating the transition to ISO 13485:2016, ensuring adherence to updated FDA regulations. Their services are designed to integrate with a client's quality system, fulfilling regulatory obligations across multiple international markets.
Key Highlights
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MDSS provides FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers.
Source
“MDSS provides professional and fully compliant FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers.”
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Offers EU Authorized Representation, UK Responsible Person, and QMSR compliance services.
Source
“They specialize in EU Authorized Representation, FDA U.S. Agent services, and QMSR compliance.”
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Has 30 years of global regulatory experience.
Source
“With 30 years of global regulatory experience, MDSS provides a reliable and cost-effective solution to meet your FDA obligations.”
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Acts as a liaison with the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
Source
“At MDSS, we redefine excellence as your Authorized Representative, serving as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.”
Certifications & Trust Signals
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MDSS is a member of the European Association of Authorized Representatives (EAAR).
Source
“MDSS is a member of the European Association of Authorized Representatives (EAAR)”
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MDSS is a member of the UK Responsible Person Association (UKRPA).
Source
“the UK Responsible Person Association (UKRPA)”
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MDSS is a member of Swiss Medtech.
Source
“Swiss Medtech”
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MDSS is a member of the Medical Technology Association of Australia (MTAA).
Source
“and the Medical Technology Association of Australia (MTAA).”
Buyer Snapshot
Best for
- Non-U.S. medical device and IVD manufacturers seeking FDA U.S. Agent services.
- Companies needing EU Authorized Representation or UK Responsible Person services.
- Manufacturers preparing for QMSR compliance.
How engagement typically works
- Acting as a direct liaison with regulatory authorities.
- Providing expert guidance on compliance requirements.
- Facilitating market entry and ongoing regulatory adherence.
Typical deliverables
- Designated FDA U.S. Agent.
- EU Authorized Representative services.
- UK Responsible Person services.
- QMSR compliance review and support.
- Regulatory representation to various national authorities.
Good to know
- Best when requiring a dedicated U.S. Agent for FDA communication.
- Ideal for companies expanding into the EU, UK, USA, Switzerland, or Australia.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $499–$999 Per Month
Notes:
Based on publicly listed information; final fees depend on scope.
“$499Per Month; $699Per Month; $999Per Month”
HQ:
Schleswig, DE
Languages:
English, German, French, Spanish
Timezones:
CET, EST
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Product Type:
devices
Annual Renewal Support:
No
Registration Support:
Yes
Recall Support:
No
Inspection Support:
No
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
Additional us_agent_fda Details
Product Types
Medical Devices, IVDs
Registration Support
Yes, as part of U.S. Agent services.
Recall Support
Implied through liaison role with FDA
Inspection Support
Implied through U.S. Agent role as liaison
US Entity State
Illinois (based on Chicago address)
Onboarding Steps
MDSS ensures manufacturers meet all mandatory requirements under U.S. FDA regulations and simplifies the path to the U.S. market.
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