Medical Device Safety Service

What Medical Device Safety Service does

Medical Device Safety Service (MDSS) is a privately-held regulatory services company headquartered in Hannover, Germany, founded in 1994. It functions as an authorized representative and in-country representation provider for medical device and in vitro diagnostic (IVD) manufacturers based outside major regulated markets who need to place products in the EU, UK, Switzerland, USA, Australia, and New Zealand. Its core services include EU Authorized Representative (EC REP), UK Responsible Person (UKRP), Swiss Authorized Representative (CH-REP), U.S. Agent to the FDA, and Australian & New Zealand Sponsor services, along with complementary offerings such as EUDAMED registration management, national registrations, free sales certificates, CE Marking support, GDPR representation, GSPR representation, AI Act representation, and importer-of-record services.

MDSS operates through wholly-owned subsidiaries (MDSS GmbH, MDSS-UK RP Ltd., MDSS CH GmbH, MDSS AU PTY LTD, MDSS NZ, MDSS-Impex GmbH, MDSS Consulting GmbH, and MDSS Cosmetics), with offices in Hannover, Chicago, Manchester, Aarau, and Sydney. Its technology stack is non-software: the proprietary capability is regulatory domain expertise, established relationships with notified bodies and regulatory authorities, ISO 13485:2016-certified quality management (BSI-certified, February 2024), and accumulated EUDAMED registration records that create switching friction for incumbent clients. The company holds ISO 13485:2016 certification from BSI as the principal quality credential.

MDSS makes money through professional-services fees for authorized representation and regulatory consulting on multi-year contracts. Pricing is quote-based with free initial consultations and quotes returned within 24 hours. GTM is sales-led and direct to enterprise manufacturers, supported by content marketing (blog/News & Views), an education platform (MDSS Forum+), on-site workshops, seminars, LinkedIn presence, email newsletters, and industry events (including RAPS Convergence). Leadership includes Heinz Steneberg as President & CEO of MDSS USA LLC and Carla Lemos as Sales & Marketing Director. The company has no disclosed external funding, parent company, or acquisition history.

Name

Medical Device Safety Service

Legal name

MDSS USA LLC

Website

https://mdss.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Medical Device Safety Service (MDSS) is a Hannover-based authorized representative providing in-country regulatory representation for medical device and IVD manufacturers seeking market access to the EU, UK, Switzerland, USA, Australia, and New Zealand.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Services

NAICS

Other Legal Services (54119)

SIC

Services-Health Services (8000)

akta.pro primary industry

Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)

akta.pro secondary industry

Healthcare & Clinical Professional Development (CME/CE) (EDAGANAJ)

Keywords

• Medical device regulatory services
• Authorized representative services
• EU MDR compliance
• In-country representation
• IVD regulatory consulting

Headquarters

HQ city

Hanover

HQ country

Germany

HQ region

Europe

Offices6 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. In-Country Representation Services: MDSS generates revenue through fees for authorized representative services, regulatory consulting, and related compliance services. Services include EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent, and Australian/New Zealand Sponsor services. The company also offers Free Sales Certificates, National Registrations, and GDPR/GPSR representation services.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

MDSS provides In-Country Representation services for non-EU/UK/Swiss/US/Australian/New Zealand-based medical device and IVD manufacturers, acting as their EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent to the FDA, and Australian/New Zealand Sponsor. The company also handles EUDAMED registrations, national registrations, Free Sales Certificates, importer services, CE marking support, and related regulatory consulting across multiple jurisdictions.

Product overview

MDSS is a regulatory services company providing In-Country Representation services for Medical and In Vitro Diagnostic Devices across multiple jurisdictions. The company operates a platform of authorized representative services, including EU Authorized Representative (EC REP), UK Responsible Person (UKRP), Swiss Authorized Representative (CH-REP), U.S. Agent to the FDA, and Australian & New Zealand Sponsor. Additional services include GDPR Representative, GSPR Representative, AI Act Representative, Clinical Investigation Representative, National Registrations, Free Sales Certificates, Importer Services (MDSS-Impex GmbH), and CE Marking support. The company also offers regulatory consulting through MDSS Consulting GmbH, cosmetics compliance through MDSS Cosmetics, and education/training services including MDSS Forum+ and workshops. MDSS has been in business for over 30 years with offices in Germany (HQ), USA, UK, Switzerland, and Australia.

Differentiator

Problem solved

Functional benefit

Brands

• MDSS Forum+: Education and training platform offering workshops, seminars, and regulatory guidance for manufacturers
• MDSS Consulting
• MDSS Cosmetics

Products and services

• EU Authorized Representative (EC REP) Provides authorized representative services for non-EU based medical device companies to place devices in the EU market, assisting with EU Registration with European Authorities under MDR (EU) 2017/745.
• UK Responsible Person (UKRP) Provides UK Responsible Person services for non-UK based medical device companies to place devices in the UK market, assisting with UK Registration with the MHRA.
• Swiss Authorized Representative (CH-REP) Provides Swiss Authorized Representative services for non-Swiss based medical device companies to place devices in the Swiss market, assisting with Swiss Registration with Swissmedic.
• U.S. Agent to the FDA Provides U.S. Agent services for non-U.S. medical device companies to register devices with the FDA and access the US market through MDSS USA LLC.
• Australian & New Zealand Sponsor Provides Australian & New Zealand Sponsor services for non-Australian/non-New Zealand based medical device companies to launch devices in these markets, assisting with TGA registration and Medsafe notification.
• GDPR Representative Service Acts as EU Representative for GDPR compliance under Regulation (EU) 2016/679 for processors/controllers located outside the EU serving EU customers.
• GSPR - General Product Safety Regulation Representative Acts as EU Representative for GPSR compliance under Regulation (EU) 2023/988 for manufacturers not established in the EU.
• AI Act Representative Acts as EU Representative for AI Act compliance under Regulation (EU) 2024/1689 for providers of high-risk AI systems located outside the EU.
• Representative for Clinical Investigations Provides representative services for sponsors of clinical investigations or clinical studies based outside the EU, UK, Switzerland, or USA to ensure compliance with regulatory obligations.
• National Registrations Performs National Registrations on behalf of manufacturers and offers Global Medical Device Nomenclature (GMDN) code research.
• Free Sales Certificate (FSC) & CFS Provides support during the application process for Free Sales Certificates / Certificate of Marketability in the EU, UK, or Switzerland for non-European countries.
• Importer of Products to the European Market MDSS-Impex GmbH places devices from third countries on the European Market according to European Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746.
• MDSS Consulting GmbH - Regulatory Consulting Provides comprehensive regulatory consulting services from initial strategy development to market launch, helping navigate complex medical device and IVD regulations.
• MDSS Cosmetics Provides Safety and legal compliance services for cosmetic products as Responsible Person (RP) for Cosmetics Representation in the EU and UK under Cosmetics Regulations, and as U.S. Agent under FDA MoCRA.
• CE Marking Supports medical devices, in vitro diagnostic devices, and implantable medical devices with CE marking compliance under MDR (EU) 2017/745 and IVDR (EU) 2017/746, including determination of device classification and declaration of conformity.
• Education & Training - MDSS Forum+ & Workshops Provides education and training services including MDSS Forum+, 1-day and 2-day on-site workshops on CE Marking MDR implementation, upcoming seminars, and GSPR compliance checklists.

Quantifiable outcome

• 5 or 15 business days timelines for service delivery
• +1 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Seven partnerships are on record, tiered core.

• MDSS Consulting GmbHcoreStrategic or Co-development PartnerMDSS Consulting GmbH offers comprehensive regulatory consulting services for medical devices and IVDs, providing support from initial strategy development to market launch. Located at the same Hannover, Germany address as MDSS GmbH.
• MDSS CosmeticscoreStrategic or Co-development PartnerMDSS Cosmetics provides services as Responsible Person for Cosmetics Representation in the EU and UK under Cosmetics Regulations, and as U.S. Agent under FDA Regulations - Modernization of Cosmetics Regulation Act (MoCRA).
• MDSS-Impex GmbHcoreStrategic or Co-development PartnerMDSS-Impex GmbH places devices from third countries on the European Market according to European Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746. Located in Hannover, Germany.
• MDSS-UK RP Ltd.coreStrategic or Co-development PartnerMDSS-UK RP Ltd. performs and assists UK Registration with the MHRA as UK Responsible Person for medical devices in the UK market. Located in Manchester, UK.
• MDSS CH GmbHcoreStrategic or Co-development PartnerMDSS CH GmbH assists Swiss Registration with Swissmedic as Swiss Authorized Representative. Located in Aarau, Switzerland.
• MDSS AU & MDSS NZcoreStrategic or Co-development PartnerMDSS AU PTY LTD performs and assists with registration required by TGA (Australia) and notification required by Medsafe (New Zealand) as Australian & New Zealand Sponsor. Located in Sydney, Australia.
• MDSS USA LLCcoreStrategic or Co-development PartnerMDSS USA LLC assists with US Registration required by the FDA as U.S. Agent for non-U.S. medical device companies. Located in Chicago, Illinois, USA. President & CEO: Heinz Steneberg.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• MDI Consultants: MDI Consultants provides regulatory affairs, quality assurance, and authorized representation services for medical device companies, directly overlapping with MDSS's core in-country representation portfolio.
• Emergo by UL: Emergo by UL is one of the largest global providers of EU Authorized Representative, UK Responsible Person, and in-country regulatory representation services for medical device and IVD manufacturers—directly competing with MDSS across the same product categories and customer base.
• NAMSA: NAMSA is a medical device-focused regulatory, quality, and clinical research consulting firm; it serves a comparable manufacturer client base and overlaps with MDSS Consulting on regulatory strategy and EU/UK/FDA market access.
• Advena Ltd: Advena is a dedicated EU Authorized Representative and UK Responsible Person service provider for medical device manufacturers, competing head-to-head with MDSS in the same regulatory representation niche.
• RQM+: RQM+ provides regulatory affairs, quality, and clinical consulting for medical devices including authorized representative services, overlapping with MDSS on EC REP, UKRP, and FDA U.S. Agent offerings for non-EU/UK/US manufacturers.
• MedCert International: MedCert provides EU Authorized Representative and IVDR/MDR compliance services for non-EU medical device manufacturers, closely mirroring MDSS's core authorized representation value proposition.

Emerging players

• Johner Institute: Johner Institute focuses on regulatory affairs consulting, training, and CE marking support for medical device manufacturers, partially overlapping with MDSS's MDSS Consulting and MDSS Forum+ education offerings.

Broad incumbents

• TÜV SÜD: TÜV SÜD is a large notified body offering medical device testing, certification, and increasingly authorized representation support; it overlaps with MDSS for manufacturers seeking bundled compliance services across multiple jurisdictions.
• DEKRA Certification: DEKRA provides medical device certification, testing, and regulatory support services globally, competing with MDSS on CE marking, ISO 13485, and broader compliance offerings for medical device manufacturers.
• BSI Group: BSI is a major notified body and ISO 13485 certification body that also offers regulatory representation and CE marking services; it sits as a broader incumbent that awarded MDSS its ISO 13485 certificate and competes in adjacent regulatory services.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/medicaldevicesafetyservice
• Xx.com/MDSS_Team

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medical Device Safety Service