MDSS
MDSS provides expert In-Country Representation and regulatory affairs services for medical and IVD devices, specializing in EU Authorized Representation and FDA U.S. Agent services.
MDSS is a seasoned provider of In-Country Representation and regulatory affairs services, boasting over 30 years of experience assisting medical and in vitro diagnostic device manufacturers. They specialize in navigating complex regulatory landscapes, offering services such as EU Authorized Representation, UK Responsible Person, Swiss Authorized Representative, and U.S. Agent services. For non-EU manufacturers, MDSS acts as a crucial liaison with regulatory bodies like the FDA, ensuring seamless market access and compliance with U.S. FDA regulations. They also provide expert guidance on evolving regulations such as the AI Act and QMSR, helping clients meet all mandatory requirements and minimize risks. MDSS is committed to simplifying the regulatory journey for their clients, allowing them to focus on innovation and core business operations.
About
**Who they are**
MDSS provides professional and compliant FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, acting as a liaison with the FDA to meet regulatory requirements.
**Expertise & scope**
* Serves as the official FDA U.S. Agent for foreign manufacturers registered with the FDA.
* Facilitates communication between manufacturers and the FDA.
* Offers expert In-Country Representation and regulatory affairs services.
* Specializes in EU Authorized Representation and FDA U.S. Agent services.
* Provides services for medical and IVD devices.
* Assists with meeting mandatory requirements under U.S. FDA regulations.
* Supports market access to the United States.
* Offers guidance on Quality Management System Regulation (QMSR) compliance, aligning with ISO 13485:2016.
**Reputation / proof points**
* 30 years of global regulatory experience.
* 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).
* Has a presence in the USA, EU, UK, Switzerland, and Australia.
MDSS provides professional and compliant FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, acting as a liaison with the FDA to meet regulatory requirements.
**Expertise & scope**
* Serves as the official FDA U.S. Agent for foreign manufacturers registered with the FDA.
* Facilitates communication between manufacturers and the FDA.
* Offers expert In-Country Representation and regulatory affairs services.
* Specializes in EU Authorized Representation and FDA U.S. Agent services.
* Provides services for medical and IVD devices.
* Assists with meeting mandatory requirements under U.S. FDA regulations.
* Supports market access to the United States.
* Offers guidance on Quality Management System Regulation (QMSR) compliance, aligning with ISO 13485:2016.
**Reputation / proof points**
* 30 years of global regulatory experience.
* 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).
* Has a presence in the USA, EU, UK, Switzerland, and Australia.
Additional information
MDSS simplifies the path to the U.S. market for foreign medical device and IVD manufacturers by acting as their official FDA U.S. Agent. This role is a legal requirement for non-U.S. entities registered with the FDA, serving as a crucial communication link. MDSS leverages its 30 years of global regulatory experience to ensure compliance, minimize risks, and prevent costly delays in market entry. They also offer expertise in navigating the FDA's Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016, providing a cost-effective solution for compliance reviews.
Key Highlights
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MDSS 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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Provides FDA U.S. Agent services for 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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Acts as a trusted liaison with the FDA for foreign manufacturers.
Source
“As your trusted liaison with the FDA, we help you meet all mandatory requirements under the U.S. FDA regulations.”
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Offers expert guidance on FDA Quality Management System Regulation (QMSR) compliance.
Source
“Reach out to Heinz, H.Steneberg@mdssar.com, today and take advantage of our cost-effective, expert-led QMSR compliance review.”
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 manufacturers seeking FDA U.S. Agent services.
- IVD manufacturers requiring regulatory representation in the U.S.
How engagement typically works
- Acting as a direct liaison with the FDA.
- Providing expert guidance on U.S. regulatory requirements.
Typical deliverables
- FDA U.S. Agent representation.
- Support for FDA establishment registration and device listing.
- Guidance on QMSR compliance.
- Facilitation of communication with U.S. regulatory authorities.
Good to know
- Best when requiring a dedicated U.S. Agent for FDA compliance.
Pricing
Model:
Retainer
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
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVDs
Portfolio:
26-100, 100+
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
USD 2,000
Included services:
FDA communications handling, Establishment registration support, Device listing assistance, Inspection coordination, Annual renewal reminders
Product Type:
devices
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
No
Inspection Support:
Yes
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
Inspection Support
Implied through liaison role
Emergency Contact24x7
Not explicitly stated
US Entity State
Illinois (based on Chicago address)
Onboarding Steps
Implied need to establish communication and meet FDA requirements.
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