Nemius Group
NEMIUS Medical Europe GmbH & Co. KG (Nemius Group) is a German consulting firm providing quality management, regulatory affairs, audit, and outsourced personnel services to medical device manufacturers and in-vitro diagnostics companies across Germany, Europe, Switzerland, and the UK.
- Company typePrivate
- Founded2012
- HeadquartersOffenbach, Germany
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Nemius Group does
NEMIUS Medical Europe GmbH & Co. KG, operating as Nemius Group, is a German professional services firm founded in 2012 that provides quality management, regulatory affairs, and audit consulting to medical device manufacturers and in-vitro diagnostics companies. The firm is headquartered in Mainz with a second office in Frankfurt am Main, and operates across Germany, Europe, Switzerland, and the United Kingdom. Its Managing Director is Thorsten Schmitt, M.Sc., and the entity is structured as a GmbH & Co. KG with NEMIUS Union GmbH as the personally liable partner.
The company delivers its offering through three core service lines. Consulting covers QM system development, implementation and optimization, regulatory affairs (technical documentation, risk management, biocompatibility, sterilization, market approvals), audits (internal, supplier, mock, gap), and reportable incident/EUDAMED compliance. External Functions provides outsourced regulatory personnel, including European Authorized Representatives, Responsible Persons under MDR/IVDR, Project Management Officers, Safety Officers for Medical Devices, and interim Quality Management Representatives. Academy offers public seminars and certifications — CAPA workshops, EN ISO 13485 Lead and Internal Auditor, Quality Representative, and §83 MPDG medical device consultant training — with publicly disclosed pricing from €589 to €2,595 per seat. The NEMIUS Cloud platform (nemius.cloud) supports client access and seminar management, and a Micro-Consulting offering enables short-term, transaction-priced engagements for ad-hoc questions.
Go-to-market is sales-led via the company website, contact forms, appointment booking, and direct consultation, supplemented by industry presence at MEDICA | Compamed and MDR-Forum. Revenue is generated entirely through professional services — project consulting fees, recurring outsourced personnel engagements, and seminar fees — with no disclosed funding, M&A activity, or external investment in the available data.
Nemius Group firmographics
Firmographics- Name
- Nemius Group
- Legal name
- NEMIUS Medical Europe GmbH & Co. KG
- Website
- https://nemius.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- NEMIUS Medical Europe GmbH & Co. KG (Nemius Group) is a German consulting firm providing quality management, regulatory affairs, audit, and outsourced personnel services to medical device manufacturers and in-vitro diagnostics companies across Germany, Europe, Switzerland, and the UK.
- Ownership category
- akta.pro rank
Nemius Group industry classification
Industry- Product category
- Medical Device Regulatory Consulting
- NAICS
- Management Consulting Services (54161), Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Management Consulting Services (8742)
- akta.pro primary industry
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)
- akta.pro secondary industries
- Training & Competency Programs for GxP Compliance (HLAGAKAM), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
Keywords
Where Nemius Group is headquartered
LocationHeadquarters
- HQ city
- Offenbach
- HQ country
- Germany
- HQ region
- Europe
Offices2 records
Markets served
Nemius Group business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- Consulting Services: Professional consulting services for quality management systems, regulatory affairs, and audit support for medical device manufacturers. Services are delivered by expert consultants and billed according to project scope and time investment.
- Academy and Training: Seminar and training programs on quality management, regulatory affairs, and audit skills for medical device professionals. Programs include certifications such as Lead Auditor Medical Devices, Internal Auditor, and Quality Representative Medical Devices.
- External Functions: Providing external personnel for roles such as European Authorized Representative for Medical Products, Responsible Person (MDR/IVDR), Project Management Officer, Safety Officer for Medical Devices, and Quality Management Representative (QMB).
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | CAPA - Basiswissen + Workshop | Corrective and Preventive Actions (2 days) |
| One time/ perpetual license | Pay-as-you-go | CAPA - Workshop | Corrective and Preventive Actions (1 day) |
| One time/ perpetual license | Pay-as-you-go | CAPA - Basiswissen | Corrective and Preventive Actions (1 day) |
| One time/ perpetual license | Pay-as-you-go | Medizinprodukteberater gemäß §83 MPDG (1 day) |
| One time/ perpetual license | Pay-as-you-go | Lead Auditor Medical Devices | ISO 13485 (5 days) |
| One time/ perpetual license | Pay-as-you-go | Interner Auditor Medical Devices | EN ISO 13485 (2 days) |
| One time/ perpetual license | Pay-as-you-go | Qualitätsmanagement - Anforderungen verstehen | EN ISO 13485 (2 days) |
| One time/ perpetual license | Pay-as-you-go | Qualitätsmanagement - Basiswissen | EN ISO 13485 (1 day) |
| One time/ perpetual license | Pay-as-you-go | Quality Representative Medical Devices | ISO 13485 (Seminar package) |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels5 records
Nemius Group product offering
Product offeringCore offering
Nemius Group provides professional consulting, external regulatory personnel services, and certified training programs for medical device and in-vitro diagnostics manufacturers. Its core offerings include quality management system development and implementation, regulatory affairs support for market approvals under MDR/IVDR, audit preparation, incident reporting compliance, and provision of external personnel serving as European Authorized Representatives, Responsible Persons, and Quality Management Representatives.
Product overview
NEMIUS (NEMIUS Medical Europe GmbH & Co. KG) is a consulting and training services company for medical devices and in-vitro diagnostics. The company offers an integrated portfolio comprising three core offerings: Consulting services for quality management, regulatory affairs, audits, and incident reporting; External Functions providing personnel for authorized representative, responsible person, and quality management roles; and Academy providing professional training seminars. The offerings are supported by the NEMIUS Cloud platform for client access and seminar management. Services span Germany, Europe, Switzerland, and the United Kingdom, with locations in Mainz and Frankfurt am Main.
Differentiator
Problem solved
Functional benefit
Products and services
- Consulting Professional consulting services for medical device manufacturers covering quality management, regulatory affairs, audits, and incident reporting compliance. Includes sub-services for QM system development, implementation and advancement, regulatory product design, technical documentation, risk management, biocompatibility, sterilization, market approvals, and MDR/IVDR compliance.
- External Functions (Externe Funktionen) External personnel services providing authorized representatives for medical devices, responsible persons under MDR/IVDR, project management officers, safety officers for medical devices, and quality management representatives as defined roles for client companies.
- Academy (Seminars & Training) Professional training and seminar services for medical device industry professionals. Includes courses on CAPA (Corrective and Preventive Actions), quality management according to EN ISO 13485, internal and lead auditor certification, and medical device consultant training per §83 MPDG.
- Micro-Consulting Short-term consulting service for specific individual questions and challenges in medical device regulatory affairs and quality management.
- NEMIUS Cloud Cloud-based platform for client access to NEMIUS services, seminar management, and training resources.
Companies that use Nemius Group
Customer profileSegments3 records
Ideal customer profiles3 records
Nemius Group technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Nemius Group partnerships and signals
Strategic signalScale indicators1 record
Recent moves6 records
Expansion highlights5 records
Nemius Group competitors and assessment
Company assessmentDirect peers
- Qserve Group: Netherlands-headquartered regulatory and quality consultancy specialized in medical devices and IVDs, with a strong MDR/IVDR focus and global footprint. Comparable service mix (consulting, training, authorized representative services) makes it a near-direct international peer.
- Johner Institut: German medical device and IVD regulatory/quality consulting firm offering QM, regulatory affairs, software-as-a-medical-device support, and training. The most direct head-to-head competitor to Nemius in the DACH medtech consulting market.
Broad incumbents
- NSF International: Global public health and safety organization providing medical device testing, certification (ISO 13485), and regulatory consulting. Competes with Nemius in QMS certification support and training for medtech professionals.
- UL Solutions: Global safety science company offering medical device testing, certification, regulatory support, and training. Significant overlap with Nemius on regulatory affairs consulting and standards-based training for medtech manufacturers.
- TÜV SÜD: Large global testing, inspection, certification, and training organization offering ISO 13485 certification, MDR-related services, and medtech training. Overlaps with Nemius on QMS audits, certification training, and authorized representative-adjacent services, but as a much broader portfolio player.
- BSI Group: International standards and certification body issuing ISO 13485 certifications and offering medical device regulatory training. Comparable on certification and training, but operates across many industries and geographies.
- DQS Medizinprodukte: German-headquartered certification body running ISO 13485 audits and medical device management system certifications. Direct overlap with Nemius' audit preparation and Lead Auditor training services from a large, established incumbent angle.
- DEKRA: Global testing, inspection, and certification company with medical device QMS auditing and certification services. Competes with Nemius on ISO 13485 certification and training, though within a much wider industrial-services portfolio.
Others
- RAPS (Regulatory Affairs Professionals Society): Global professional society for regulatory affairs professionals offering training, certifications, and publications in medical device and pharmaceutical regulatory affairs. Adjacent to Nemius' Academy arm — same buyer persona but association model rather than consultancy.
Emerging players
- medicaldeviceHQ / MRC Global (MedEnvoy / Medidee): European medical device regulatory and quality consulting boutique offering services across MDR/IVDR, clinical evaluation, and authorized representation. Comparable niche positioning to Nemius but smaller, with a different geographic center of gravity (Switzerland).
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Nemius Group social profiles
Digital presenceNemius Group financial estimates
Financial estimateRevenue estimate
Valuation estimate
Nemius Group leadership team
Management profileNumber of profiles
Profiles1 record
Nemius Group funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Nemius Group M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Nemius Group
What does Nemius Group do?
Nemius Group provides professional consulting, external regulatory personnel services, and certified training programs for medical device and in-vitro diagnostics manufacturers. Its core offerings include quality management system development and implementation, regulatory affairs support for market approvals under MDR/IVDR, audit preparation, incident reporting compliance, and provision of external personnel serving as European Authorized Representatives, Responsible Persons, and Quality Management Representatives.
Is Nemius Group a public or private company?
Nemius Group is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Nemius Group founded?
Nemius Group was founded in 2012. It employs 11 to 50 people.
Where is Nemius Group based?
Nemius Group is headquartered in Offenbach, Germany, in the Europe region.
How does Nemius Group make money?
Three revenue lines are on record. Consulting Services are the primary driver. The others are academy and Training and external Functions.
Who are Nemius Group's main competitors?
Direct peers on record are Qserve Group and Johner Institut. Broad incumbents are NSF International, UL Solutions, TÜV SÜD, BSI Group, DQS Medizinprodukte and DEKRA. RAPS (Regulatory Affairs Professionals Society) is listed as an others. medicaldeviceHQ / MRC Global (MedEnvoy / Medidee) is listed as an emerging player.
Does Nemius Group have an API?
No public API is recorded for Nemius Group.
What industry is Nemius Group in?
Nemius Group's product category is Medical Device Regulatory Consulting. Its primary akta.pro industry code is HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight), with a secondary code of HLAGAKAM, Training & Competency Programs for GxP Compliance. Its NAICS code is 54161 and its SIC code is 8742.