QMD Services

What QMD Services does

QMD Services GmbH is an Austrian Notified Body (NB 2962) that performs conformity assessment and certification for medical devices under EU Regulation 2017/745 (MDR) and for in vitro diagnostic medical devices under EU Regulation 2017/746 (IVDR). The organization is headquartered in Vienna with an operations office in Linz, employs approximately 20 people, and operates as a private GmbH wholly owned by Quality Austria. Its core services are technical documentation assessment, quality management system audits, and CE certificate issuance conducted per Annex IX and Annex XI of the respective regulations, supplemented by EN ISO 13485 and ISO 9001 system certification delivered in collaboration with Quality Austria Group.

The business is a professional services enterprise whose revenue is generated through multi-year, risk-class-based conformity assessment contracts priced by device class, number of devices, technology complexity, and ongoing surveillance activities over a five-year certification cycle. The go-to-market motion is enterprise field sales: manufacturers initiate contact via an online application, receive a free feasibility check, a tailored quotation, and structured project management through to certification. QMD Services also distributes a Knowledge Base of whitepapers and webinars on regulatory topics such as MDR Article 117, IVD legacy devices, and medical software and AI, and operates an international partner network spanning the US (UL LLC), Turkey (IFC Global, TSE Global), and China (Shanghai OQS International), while holding membership in Team-NB.

Name

QMD Services

Legal name

QMD Services GmbH

Website

https://qmdservices.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

QMD Services is an Austrian Notified Body (NB 2962) that performs CE conformity assessment for medical device and IVD manufacturers under EU MDR and IVDR regulations, serving enterprise clients across Europe with technical documentation review, QMS audits, and ISO certification.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Certification

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Testing Laboratories (8734), Services-Health Services (8000)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Conformity assessment services
• Medical device certification
• CE marking certification
• Notified body services
• Regulatory compliance audits

Headquarters

HQ city

Vienna

HQ country

Austria

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. IVDR Conformity Assessment: Conformity assessment services under Regulation (EU) 2017/746 for in vitro diagnostic medical devices, including technical documentation review, QMS audits, and CE certificate issuance. Fees calculated based on device risk classification, number of devices, complexity, and surveillance activities over the device lifecycle.
2. MDR Conformity Assessment: Conformity assessment services under Regulation (EU) 2017/745 for medical devices, covering technical documentation assessment, quality management system audits, and CE marking certification. Pricing based on device class, number of devices, regulatory complexity, and ongoing surveillance requirements.
3. System Certification: System certification services according to EN ISO/IEC 17021-1 for EN ISO 13485 and ISO 9001, offered in collaboration with Quality Austria Group. These certifications complement device conformity assessments for manufacturers.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

QMD Services is a notified body (NB 2962) providing conformity assessment services for medical devices under EU Regulation 2017/745 (MDR) and in vitro diagnostic medical devices under EU Regulation 2017/746 (IVDR). The company conducts technical documentation assessments, quality management system audits, and issues CE certificates that are mandatory for European market access. It also delivers EN ISO 13485 and ISO 9001 system certification in collaboration with Quality Austria Group.

Product overview

QMD Services is a notified body (NB number 2962) providing conformity assessment and certification services for medical devices and in vitro diagnostics under EU regulations. The company offers two core conformity assessment services: IVDR Conformity Assessment (EU 2017/746) and MDR Conformity Assessment (EU 2017/745), both conducted through Quality Management System audits and technical documentation review. Additionally, the company provides System Certification for ISO 13485 and ISO 9001 quality management systems. A Knowledge Base resource offers whitepapers, regulatory guidance, and webinars on medical device compliance topics. The services follow a structured 10-step certification process from initial contact through certificate issuance and ongoing surveillance maintenance.

Differentiator

Problem solved

Functional benefit

Segments3 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Six partnerships are on record, tiered core and minor.

• Quality Austria GroupcoreStrategic or Co-development PartnerQMD Services is owned by Quality Austria. The organizations collaborate on system certification services, with QMD Services offering EN ISO/IEC 17021-1 certifications for EN ISO 13485 and ISO 9001 through this partnership. Quality Austria provides institutional backing and access to broader quality certification expertise.
• UL LLCminorStrategic or Co-development PartnerUL LLC is a US-based global safety science company (333 Pfingsten Road, Northbrook, IL, USA) listed as a QMD Services partner for providing services to clients worldwide. Nature of cooperation focuses on extending service reach internationally.
• IFC GlobalminorStrategic or Co-development PartnerIFC Global (Sertifikasyon Muayene ve Eğitim Hizmetleri Anonim Şirketi) is based in Bayrakli, Izmir, Turkey. Listed as a QMD Services partner for worldwide client service provision.
• Shanghai OQS International (China) CO., LTD.minorStrategic or Co-development PartnerShanghai OQS International (China) CO., LTD. is located at 6th Floor, Jingheng Daye Plaza, Nr. 2008 Huqingping Road, Shanghai. Listed as a QMD Services partner for international cooperation and client services.
• TSE GlobalminorStrategic or Co-development PartnerTSE Global is based in Dudullu OSB Mahallesi 3. Cadde, No:13, 34776 Ümraniye Istanbul/Turkey. Listed as a QMD Services partner for worldwide service provision to clients.
• Team-NBminorStrategic or Co-development PartnerQMD Services is a member of Team-NB, a network of European Notified Bodies for medical devices. Membership provides access to industry working groups, task force participation, and knowledge sharing among notified bodies.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Quality Austria: Parent company of QMD Services, offering broader quality management certification including ISO 9001 and ISO 13485. Overlapping service portfolio, with QMD Services handling the regulated medical device conformity assessment subspecialty.
• UL Solutions: Global safety science company with notified body activities and a broader portfolio of testing, inspection, and certification. Listed as a QMD Services partner and competes in adjacent certification services.

Direct peers

• TÜV Rheinland: Major Notified Body offering MDR and IVDR conformity assessment, with global operations and a deep roster of medical device clients. Serves the same customer base as QMD Services with overlapping service scope.
• DEKRA: International Notified Body designated under MDR and IVDR, providing CE marking services for medical devices and IVDs. Competitor for European medical device manufacturer certification engagements.
• IMQ (Istituto Italiano del Marchio di Qualità): Italian Notified Body providing CE marking certification for medical devices and IVDs. Comparable in size and scope to QMD Services, focused on European medical device manufacturers.
• NSAI: Irish National Standards Authority operating as a Notified Body for medical devices under MDR. Comparable mid-sized European notified body competing for similar manufacturer clients.
• TÜV SÜD: One of the largest global Notified Bodies for medical devices under MDR and IVDR, with broad European coverage and significant assessment capacity. Directly comparable to QMD Services in service offering, though much larger in scale and geographic reach.
• BSI Group: UK-based Notified Body with significant MDR and IVDR designation scope, serving medical device manufacturers globally. Directly competes with QMD Services for certification contracts in the European market.

Regional players

• TSE Global: Turkish-based certification partner listed by QMD Services for international client services. Operates in adjacent certification markets regionally; comparable business model focused on quality and conformity assessment services.

Others

• Team-NB: European association of Notified Bodies for medical devices. QMD Services is a member; relevant as an industry body that shapes notified body standards and represents the collective interests of notified bodies including QMD Services.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• LinkedInlinkedin.com/company/qmdservices

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 QMD Services