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, specializing in FDA U.S. Agent 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.
* Serves as a communication link between foreign manufacturers and the U.S. FDA.
* Ensures compliance with mandatory U.S. FDA regulations.
* Expertise in EU Authorized Representation, FDA U.S. Agent services, and QMSR compliance.
* Assists with market access to the United States.
* Provides QMSR compliance reviews, aligning with ISO 13485:2016.
**Reputation / proof points**
* 30 years of global regulatory experience.
* Serves as a pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* 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).
* Offers services in the EU, UK, Switzerland, USA, and Australia.
MDSS provides expert regulatory representation and compliance services, specializing in FDA U.S. Agent 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.
* Serves as a communication link between foreign manufacturers and the U.S. FDA.
* Ensures compliance with mandatory U.S. FDA regulations.
* Expertise in EU Authorized Representation, FDA U.S. Agent services, and QMSR compliance.
* Assists with market access to the United States.
* Provides QMSR compliance reviews, aligning with ISO 13485:2016.
**Reputation / proof points**
* 30 years of global regulatory experience.
* Serves as a pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* 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).
* Offers services in the EU, UK, Switzerland, USA, and Australia.
Additional information
MDSS simplifies the path to the U.S. market for foreign manufacturers by acting as the official FDA U.S. Agent. This role is a legal requirement for foreign entities registered with the FDA, facilitating communication and ensuring adherence to U.S. FDA regulations. They also offer specialized services for the FDA Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016. MDSS provides expert-led QMSR compliance reviews to help manufacturers navigate this transition, ensuring their quality management systems meet current standards and regulatory expectations. Their services are designed to minimize risk and avoid costly delays in market entry.
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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With 30 years of global regulatory experience, MDSS offers reliable FDA compliance solutions.
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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MDSS specializes in QMSR compliance, aligning with ISO 13485:2016.
Source
“The transition period for FDA’s Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820, will end on February 2, 2026, aligning the medical device quality system requirements with the international standard ISO 13485:2016.”
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MDSS acts as a pivotal contact for multiple regulatory authorities including the FDA, MHRA, and European Commission.
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
“MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA)”
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MDSS is a member of Swiss Medtech.
Source
“MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA) Swiss Medtech”
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MDSS is a member of the Medical Technology Association of Australia (MTAA).
Source
“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).”
Buyer Snapshot
Best for
- Non-U.S. Medical Device and IVD manufacturers seeking FDA U.S. Agent services.
- Companies needing assistance with QMSR compliance and ISO 13485 alignment.
- Manufacturers requiring regulatory representation in the EU, UK, Switzerland, USA, and Australia.
How engagement typically works
- Acts as a direct liaison with regulatory authorities.
- Provides expert guidance on regulatory requirements.
- Offers cost-effective compliance solutions.
Typical deliverables
- FDA U.S. Agent services.
- QMSR compliance reviews.
- Regulatory representation.
- Guidance on market access.
Good to know
- Best when foreign manufacturers need a U.S. point of contact for FDA communications.
- Best when companies are transitioning to the new QMSR requirements.
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
Best 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
Implied through U.S. Agent services for registered manufacturers
Recall Support
Implied through liaison role with FDA
Inspection Support
Implied through liaison role with FDA
US Entity State
Illinois (based on Chicago address)
Onboarding Steps
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