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. They serve as a pivotal contact for regulatory bodies such as the European Commission, National Competent Authorities, MHRA, Swissmedic, and the FDA.

**Expertise & scope**
* FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers, acting as a liaison with the FDA to meet mandatory requirements.
* EU Authorized Representation, including services for GPSR and GDPR.
* UK Responsible Person services.
* QMSR compliance support, assisting with the transition from 21 CFR Part 820 to ISO 13485:2016.
* Representation to regulatory authorities in the EU, UK, Switzerland, USA, and Australia.

**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).
* Offices in Germany, USA, UK, and Switzerland.

Additional information

MDSS acts as a crucial communication link between foreign manufacturers and the FDA, particularly for situations requiring direct interaction with the agency. Their services are designed to ensure manufacturers remain fully compliant with U.S. FDA regulations, thereby minimizing risks and avoiding potential delays in U.S. market entry. For QMSR compliance, they offer expert-led reviews to help manufacturers navigate the transition to ISO 13485:2016, ensuring alignment with international standards while retaining necessary FDA requirements.

Key Highlights

  • 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”
  • Specializes in FDA Quality Management System Regulation (QMSR) compliance. Source
    “The transition period for FDA’s Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820, will end on February 2, 2026”
  • 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.”

Certifications & Trust Signals

  • Member of the European Association of Authorized Representatives (EAAR). Source
    “MDSS is a member of the European Association of Authorized Representatives (EAAR)”
  • Member of the UK Responsible Person Association (UKRPA). Source
    “the UK Responsible Person Association (UKRPA)”
  • Has offices in Germany, USA, UK, and Switzerland. Source
    “Schiffgraben 41, 30175 Hannover, Germany; 6118 W. Lawrence Avenue, Chicago, IL 60630, USA; 6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK; Laurenzenvorstadt 61, 5000 Aarau, Switzerland”

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 navigating the FDA QMSR transition.
How engagement typically works
  • Acting as a direct liaison with regulatory bodies.
  • Providing expert guidance on compliance requirements.
  • Facilitating market access in the US and EU.
Typical deliverables
  • FDA U.S. Agent designation and communication.
  • EU Authorized Representative services.
  • UK Responsible Person services.
  • QMSR compliance strategy and support.
Good to know
  • Best when requiring a dedicated U.S. Agent for FDA compliance.
  • Best when needing representation in multiple international regulatory markets.

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
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

Additional us_agent_fda Details

Product Types
Medical Devices, IVDs
Registration Support
Yes
Recall Support
Implied through FDA liaison role.
Inspection Support
Yes
US Entity State
Illinois (based on Chicago address)
Onboarding Steps
Implied process to become a client and establish U.S. Agent relationship.
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