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. With 30 years of global regulatory experience, MDSS acts as a trusted liaison with the FDA, helping clients meet mandatory requirements under U.S. FDA regulations.
**Expertise & scope**
* Serves as the official FDA U.S. Agent for foreign manufacturers registered with the FDA.
* Facilitates communication between manufacturers and the FDA.
* Specializes in services for Medical Device and IVD manufacturers.
* Offers expert-led QMSR compliance review, aligning with ISO 13485:2016.
* Provides representation to the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers EU Authorized Representation, UK Responsible Person, U.S. Agent, and Australian Sponsor services.
**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).
* Provides services in the EU, UK, Switzerland, USA, and Australia.
MDSS provides professional and compliant FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers. With 30 years of global regulatory experience, MDSS acts as a trusted liaison with the FDA, helping clients meet mandatory requirements under U.S. FDA regulations.
**Expertise & scope**
* Serves as the official FDA U.S. Agent for foreign manufacturers registered with the FDA.
* Facilitates communication between manufacturers and the FDA.
* Specializes in services for Medical Device and IVD manufacturers.
* Offers expert-led QMSR compliance review, aligning with ISO 13485:2016.
* Provides representation to the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers EU Authorized Representation, UK Responsible Person, U.S. Agent, and Australian Sponsor services.
**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).
* Provides services in the EU, UK, Switzerland, USA, and Australia.
Additional information
MDSS simplifies the path to the U.S. market for medical device and IVD manufacturers by acting as their official FDA U.S. Agent. This role is a legal requirement for foreign manufacturers registered with the FDA, serving as a crucial communication link. MDSS ensures clients remain fully compliant, minimizing risks and avoiding delays in U.S. market entry. They also offer expert guidance on the FDA's Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016, ensuring manufacturers can navigate this transition effectively. Engaging MDSS can streamline regulatory obligations and facilitate market access.
Key Highlights
-
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.”
-
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.”
-
Offers representation in the EU, UK, Switzerland, USA, and Australia.
Source
“Our specialized expertise in European Regulatory Affairs positions us as your unparalleled Authorized Representative, providing a distinguished address in the EU, UK, Switzerland, USA, and Australia.”
-
Expert guidance on FDA QMSR compliance, aligning with ISO 13485:2016.
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
-
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), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).”
-
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), Swiss Medtech and the Medical Technology Association of Australia (MTAA).”
Buyer Snapshot
Best for
- Non-U.S. Medical Device and IVD manufacturers needing an FDA U.S. Agent.
- Companies seeking regulatory representation in the EU, UK, Switzerland, USA, and Australia.
How engagement typically works
- Acts as a direct liaison with regulatory bodies.
- Provides expert consultation on regulatory compliance.
Typical deliverables
- FDA U.S. Agent services.
- QMSR compliance review.
- EU Authorized Representation.
- UK Responsible Person services.
- Australian Sponsor services.
Good to know
- Best when requiring a dedicated U.S. Agent for FDA communications.
- Best when navigating complex international regulatory landscapes.
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 process involves acting as a liaison and ensuring compliance with FDA regulations and QMSR.
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare MDSS and other vetted providers — instant pricing, no RFQ needed.
