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 serves as a trusted liaison with regulatory bodies.
**Expertise & scope**
* FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, acting as a communication link with the FDA.
* Specializes in EU Authorized Representation, including GPSR and GDPR compliance.
* Offers UK Responsible Person services.
* Provides QMSR compliance services, aligning with ISO 13485:2016.
* Supports market access to the United States, ensuring compliance with U.S. FDA regulations.
* Acts as a pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
**Reputation / proof points**
* 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).
* Provides services across the EU, UK, Switzerland, USA, and Australia.
MDSS provides expert regulatory representation and compliance services for medical device and IVD manufacturers globally. With 30 years of global regulatory experience, MDSS serves as a trusted liaison with regulatory bodies.
**Expertise & scope**
* FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, acting as a communication link with the FDA.
* Specializes in EU Authorized Representation, including GPSR and GDPR compliance.
* Offers UK Responsible Person services.
* Provides QMSR compliance services, aligning with ISO 13485:2016.
* Supports market access to the United States, ensuring compliance with U.S. FDA regulations.
* Acts as a pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
**Reputation / proof points**
* 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).
* Provides services across the EU, UK, Switzerland, USA, and Australia.
Additional information
MDSS assists non-U.S. medical device and IVD manufacturers in navigating U.S. FDA regulations by acting as their official U.S. Agent. This role is a legal requirement for foreign manufacturers registered with the FDA, facilitating communication between the manufacturer and the agency. MDSS's services aim to ensure full compliance, minimize risks, and prevent delays in U.S. market entry. They also offer guidance on the transition to the FDA's Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016, helping manufacturers make necessary adjustments to their quality management systems.
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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Possesses 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 pivotal contact for multiple regulatory authorities including FDA, European Commission, and MHRA.
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
Buyer Snapshot
Best for
- Non-U.S. medical device and IVD manufacturers seeking FDA U.S. Agent services.
- Companies needing EU Authorized Representation and UK Responsible Person services.
- Manufacturers preparing for QMSR compliance.
How engagement typically works
- Acting as a direct liaison with regulatory bodies.
- Providing expert guidance on regulatory requirements.
- Facilitating market access and compliance.
Typical deliverables
- FDA U.S. Agent representation.
- EU Authorized Representative services.
- UK Responsible Person services.
- QMSR compliance support.
Good to know
- Best when requiring a dedicated point of contact for FDA communications.
- Best when needing to ensure compliance with international medical device regulations.
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 U.S. Agent role as liaison
US Entity State
Illinois (based on Chicago address)
Onboarding Steps
MDSS ensures you stay fully compliant, minimizing risk and avoiding costly delays in U.S. market entry. Let MDSS simplify your path to the U.S. market.
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