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 is a provider of regulatory affairs services, specializing in In-Country Representation and FDA U.S. Agent services for medical and IVD devices. They have 30 years of global regulatory experience.

**Expertise & scope**
* Serves as the official FDA U.S. Agent for non-U.S. Medical Device and IVD manufacturers, acting as a liaison with the FDA to meet mandatory requirements.
* Provides EU Authorized Representation, UK Responsible Person services, and representation in Switzerland, USA, and Australia.
* Offers guidance on FDA's Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016, to ensure compliance.
* Facilitates market access to the United States by ensuring compliance with U.S. FDA regulations.

**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).
* Has a presence in multiple locations including Germany, USA, UK, and Switzerland.

Additional information

MDSS assists non-U.S. medical device and IVD manufacturers in navigating the complexities of FDA U.S. Agent requirements. They act as a crucial communication link between manufacturers and the FDA, particularly for situations requiring direct FDA interaction. Their services aim to ensure full compliance, minimize regulatory risks, and prevent delays in U.S. market entry. For manufacturers transitioning to the FDA's Quality Management System Regulation (QMSR), MDSS offers expert-led compliance reviews to help align with ISO 13485:2016 standards before the February 2, 2026 deadline.

Key Highlights

  • 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.”
  • Offers EU Authorized Representation and UK Responsible Person services. Source
    “EU Authorized Representative UK Responsible Person”
  • 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.”
  • Assists with compliance for FDA's Quality Management System Regulation (QMSR). 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)”
  • MDSS is a member of the UK Responsible Person Association (UKRPA). Source
    “the UK Responsible Person Association (UKRPA)”
  • MDSS is a member of Swiss Medtech. Source
    “Swiss Medtech”
  • 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 needing an FDA U.S. Agent.
  • Companies seeking EU Authorized Representation and UK Responsible Person services.
  • Manufacturers preparing for FDA QMSR compliance.
How engagement typically works
  • Acts as a direct liaison with regulatory authorities.
  • Provides expert guidance on regulatory requirements.
  • Facilitates market access through compliance support.
Typical deliverables
  • FDA U.S. Agent services.
  • EU Authorized Representative services.
  • UK Responsible Person services.
  • QMSR compliance review and support.
Good to know
  • Best when requiring a dedicated U.S. Agent for FDA communication.
  • Ideal for companies expanding into the U.S. market for medical devices and IVDs.

Pricing

Model: Retainer
Public range: Publicly listed: $499–$999 / 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
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

Additional us_agent_fda Details

Product Types
Medical Devices, IVDs
Registration Support
Yes, implied by U.S. Agent services for registered manufacturers.
Recall Support
No explicit mention found.
Inspection Support
No explicit mention found.
Emergency Contact24x7
No explicit mention found.
US Entity State
USA
Onboarding Steps
No explicit mention found.
Request quotes
Cruxi - Regulatory Compliance Services