Mdss Gmbh

What Mdss Gmbh does

MDSS Consulting GmbH is a privately held regulatory consulting firm headquartered in Hannover, Germany, specializing in medical device and in-vitro diagnostics (IVD) regulatory affairs. Founded in 2014 as an independent spin-off from MDSS GmbH, the firm serves manufacturers, authorized representatives, importers, and distributors of medical devices and IVDs across EMEA, North America, and Oceania. The company is led by President Ludger Möller and operates without external institutional investors or a parent entity.

The firm's core service portfolio spans FDA regulatory consulting (QMSR gap assessments, 510(k) and De Novo strategy, U.S. Agent representation), quality management (EN ISO 13485, MDSAP, GMP, FDA audits), regulatory affairs (MDR/IVDR compliance, technical documentation, post-market surveillance, vigilance), clinical evaluation (CER/CEP preparation), PRRC designation, EUDAMED registration support, and European Authorized Representative (ECREP) services. Supporting offerings include document templates (priced €65–€210) sold through an online shop, workshops and training events, and free initial consultations as a lead-generation tool. The technology footprint is minimal: no proprietary platform, no app, and no API, with delivery entirely through human consulting engagements.

MDSS generates revenue primarily through professional services engagements (project-based or retainer consulting) supplemented by modest one-time license sales of document templates. The go-to-market is sales-led, utilizing content marketing via the company website, downloadable resources, and free consultations to convert inbound interest. The firm maintains a single headquarters in Hannover with no disclosed subsidiaries, providing regulatory representation and consulting services along the full product lifecycle of medical devices and IVDs.

Name

Mdss Gmbh

Legal name

MDSS Consulting GmbH

Website

https://mdssco.com

Company type

Private

Founded year

2014

Operating status

Operating

Short description

MDSS Consulting GmbH is a Hannover-based regulatory consulting firm that helps medical device and IVD manufacturers navigate FDA, EU MDR/IVDR, and multi-jurisdictional registration requirements across the full product lifecycle.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Management Consulting Services (54161), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Management Consulting Services (8742)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industry

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC)

Keywords

• Medical device consulting
• Regulatory affairs services
• IVD compliance consulting
• FDA regulatory consulting
• MDR IVDR compliance

Headquarters

HQ city

Hannover

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: The company generates revenue through providing specialized regulatory consulting services for medical device and IVD manufacturers. Services include FDA QMSR gap assessments, 510(k) strategy, MDR/IVDR compliance, quality management, clinical evaluation, EUDAMED registration, and regulatory affairs support. Engagements appear to be project-based or retainer consulting arrangements.
2. Document Templates: MDSS sells document templates for medical device compliance including risk management packets, technical documentation templates, quality management requirements templates, and essential safety/performance requirements templates. Products are sold at fixed prices ranging from €65 to €210 per template.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

MDSS Consulting GmbH provides regulatory representation and consulting services for medical device and in-vitro diagnostics (IVD) manufacturers. Core offerings span FDA regulatory consulting (QMSR gap assessments, 510(k) and De Novo strategy, U.S. Agent services), Quality Management (EN ISO 13485, MDSAP, GMP), Regulatory Affairs (MDR/IVDR compliance, technical documentation, post-market surveillance, vigilance), Clinical Evaluation (CER/CEP), PRRC, EUDAMED registration, EU country registration, and European Authorized Representative (ECREP) services for non-EU manufacturers. The company also sells editable document templates and runs regulatory training workshops.

Product overview

MDSS Consulting GmbH offers a comprehensive portfolio of regulatory consulting services for medical devices and IVDs, not a unified software platform. The core offering comprises FDA & Regulatory Consulting, Quality Management (EN ISO 13485, MDSAP, GMP), Regulatory Affairs (MDR/IVDR, technical documentation, PMS, vigilance), and Clinical Evaluation services. Supporting services include PRRC, EUDAMED registration support, EU country registration, European Authorized Representative (ECREP) services, and Free Sales Certificate issuance. The company also provides ancillary products including document templates (Risk Management, Technical Documentation, QM Requirements) in English and German, and workshops for regulatory education. The portfolio is advisory-service oriented, focused on helping manufacturers navigate MDR/IVDR, FDA, and other regulatory requirements throughout the product lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• FDA & Regulatory Consulting
• Quality Management Consulting
• Regulatory Affairs Consulting
• Clinical Evaluation Services
• PRRC (Person Responsible for Regulatory Compliance)
• EUDAMED Support & Registration
• EU Approval & Country Registration
• European Authorized Representative (ECREP)
• Free Sales Certificate (FSC/CFS)
• Document Templates (Muster-Vorlagen)
• Workshops & Training Events

Named customers5 records

Segments1 record

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators1 record

Recent moves6 records

Expansion highlights4 records

Direct peers

• Qserve Group: Qserve is a medical device and IVD regulatory consulting and CRO specializing in EU MDR/IVDR, clinical evaluation, and QMS. Direct competitor with overlapping service lines in the same EU regulatory niche.
• Johner Institut: Johner Institut is a German medical device regulatory consultancy offering MDR/IVDR consulting, clinical evaluation, and software-as-a-medical-device expertise. Strong geographic and service overlap with MDSS in the DACH region.
• Medidee Services: Medidee is a Swiss-based medical device regulatory and quality consulting firm specializing in EU MDR/IVDR compliance, clinical evaluation, and notified body interactions. Comparable boutique scale and service portfolio.
• RQM+ (Regulatory and Quality Solutions): RQM+ is a dedicated medical device and IVD regulatory/quality consulting firm offering MDR/IVDR transition, 510(k), clinical evaluation, and QMS services. Closely comparable niche focus, service portfolio, and customer base to MDSS.
• IMed Consultancy: IMed Consultancy is a medical device and IVD regulatory affairs consultancy focused on EU MDR/IVDR, FDA, and global market access. Direct competitor serving the same client segments.

Broad incumbents

• NSF (Health Sciences): NSF provides medical device regulatory consulting, training, and certification services. Comparable offerings but operates as part of a much broader health sciences and certification platform.
• Emergo by UL (UL Solutions): Emergo is UL Solutions' medical device regulatory consulting arm, providing FDA, EU MDR/IVDR, and global registration services. Most direct functional overlap with MDSS but operates at significantly larger scale and is bundled with UL's broader testing/certification platform.
• TÜV SÜD (Medical & Health Services): TÜV SÜD is a global testing, inspection, certification, and notified body with growing medical device regulatory consulting practice. Overlaps with MDSS but competes from a much larger, diversified base.
• DEKRA Certification (Medical): DEKRA is a global testing and certification organization with a medical device practice covering ISO 13485, MDR/IVDR support, and regulatory consulting. Larger, diversified competitor with similar service categories.
• BSI Group (Medical Devices): BSI is a notified body and standards organization with medical device regulatory consulting capabilities. Overlaps with MDSS in MDR/IVDR and ISO 13485, but at significantly greater scale.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Mdss Gmbh