ABOUT US

QMD Services is the only Notified Body for medical devices and in vitro diagnostic medical devices in Austria. We carry out our conformity assessment activities in full compliance with the IVDR and MDR. Our team is fully committed to ensuring the quality of the medical devices that our clients bring to the European Union market and beyond. We support our clients with lean processes and a high level of responsiveness. We offer expertise you can trust.

Our Quality Policy
We are experts for certification of medical devices

  • In our activities, we focus on assessment for safety and performance of medical devices / in-vitro diagnostics and bundle results from research, manufacturing and application.
  • Our services include conformity assessment in the role as notified body and system certification body.
  • As a premium provider, we are committed to continuously improving our services and internal processes.
  • By working in European notified body task force groups and working groups, we give our customers a knowledge advantage and winning margin with ongoing know-how transfer.
  • Compliance to applicable regulatory requirement forms the basis of our work.


We are independent, impartial and internationally recognized

  • Confidentiality, independence and impartiality are the basis of our work. We actively shape these principles and adhere to them in all our procedures.
  • We are obliged and committed to proactively comply with requirements from European regulations, national laws and standards in particular with ISO/IEC 17021-1.
  • We offer our services at international level, provided that we can uncompromisingly ensure our quality of service.
  • Compliance and independence can never be compromised for any reasons in our conformity assessment activities.


We create benefits for patients, users and manufacturers

  • Our services contribute to the innovative capacity of manufacturers, the safety of users of certified products as well as patient safety.
  • We support high standards for the quality and safety of medical devices and see our services as an important building block to test and address safety concerns regarding these products.
  • We participate in peer groups, relevant standardisation and conferences, in order to continuously update our competencies in our service provision.


We are experts from practice

  • We speak the language of our customers, but also the one for users of medical devices.
  • Our auditors, reviewers, clinical experts and trainers come with practical experience and have in-depth expert, industry and regulatory skill and knowledge.
  • Through professional education as well as exchange of experience, we ensure a high level of competence of our experts.


We work with passion and appreciation

  • We work closely together as executives, employees and service partners.
  • Strong cohesion, helpfulness, mutual appreciation and trusting relationships characterize us as a modern service company.
  • Enthusiasm and passion for our topics as well as high identification with our tasks, shape our corporate culture.

Unsere Qualitätspolitik
Wir sind Experten für die Zertifizierung von Medizinprodukten

  • In unserer Tätigkeit konzentrieren wir uns auf die Bewertung der Sicherheit und Leistung von Medizinprodukten und In-vitro-Diagnostika und bündeln Ergebnisse aus Forschung, Herstellung und Anwendung.
  • Unsere Dienstleistungen umfassen Konformitätsbewertungen in der Rolle als Benannte Stelle sowie Systemzertifizierungen.
  • Als Premiumanbieter verpflichten wir uns, unsere Dienstleistungen und internen Prozesse kontinuierlich zu verbessern.
  • Durch unsere Mitarbeit in europäischen Task-Force-Gruppen und Arbeitsgruppen der Benannten Stellen verschaffen wir unseren Kunden einen Wissensvorsprung und Wettbewerbsvorteil durch kontinuierlichen Know-how-Transfer.
  • Die Einhaltung der geltenden regulatorischen Anforderungen bildet die Grundlage unserer Arbeit.


Wir sind unabhängig, unparteiisch und international anerkannt

  • Vertraulichkeit, Unabhängigkeit und Unparteilichkeit bilden die Basis unserer Arbeit. Wir gestalten diese Prinzipien aktiv und halten sie in allen unseren Verfahren konsequent ein.
  • Wir sind verpflichtet und engagiert, die Anforderungen europäischer Verordnungen, nationaler Gesetze und Normen – insbesondere der ISO/IEC 17021 1 – proaktiv einzuhalten.
  • Wir bieten unsere Dienstleistungen auf internationaler Ebene an, sofern wir unsere Servicequalität ohne Kompromisse gewährleisten können.
  • Regelkonformität und Unabhängigkeit dürfen in unseren Konformitätsbewertungsaktivitäten aus keinerlei Gründen beeinträchtigt werden.


Wir schaffen Nutzen für Patienten, Anwender und Hersteller

  • Unsere Dienstleistungen tragen zur Innovationskraft der Hersteller, zur Sicherheit der Anwender zertifizierter Produkte sowie zur Patientensicherheit bei.
  • Wir unterstützen hohe Standards hinsichtlich Qualität und Sicherheit von Medizinprodukten und verstehen unsere Dienstleistungen als wichtigen Beitrag, um Sicherheitsaspekte dieser Produkte zu prüfen und zu adressieren.
  • Wir arbeiten an allen einschlägigen Normungsarbeiten und an der Arbeit der Koordinierungsgruppe Benannter Stellen mit und besuchen Konferenzen, um unsere Kompetenzen in der Dienstleistungserbringung kontinuierlich zu verbessern.


Wir sind Experten aus der Praxis

  • Wir sprechen die Sprache unserer Kunden – ebenso wie die der Anwender von Medizinprodukten.
  • Unsere Auditoren, Produktprüfer, klinischen Experten und Trainer verfügen über praktische Erfahrung sowie tiefgehendes Fach , Industrie und regulatorisches Wissen.
  • Durch professionelle Weiterbildung und Erfahrungsaustausch stellen wir ein hohes Kompetenzniveau unserer Experten sicher.


Wir arbeiten mit Leidenschaft und Wertschätzung

  • Als Führungskräfte, Mitarbeitende und Dienstleistungspartner arbeiten wir eng zusammen.
  • Starker Zusammenhalt, Hilfsbereitschaft, gegenseitige Wertschätzung und vertrauensvolle Beziehungen prägen uns als modernes Dienstleistungsunternehmen.
  • Begeisterung und Leidenschaft für unsere Themen sowie eine hohe Identifikation mit unseren Aufgaben prägen unsere Unternehmenskultur.

*Content controlled via POL-00106 Quality Policy / Leitlinien

We operate with strict independence, compliance, and a commitment to continuous improvement in all certification activities.

QMD Services is an Austrian-based organization that understands and identifies itself with conformity assessment and certification activities in the field of in-vitro diagnostics and medical device. Our organisation was designated as notified body according to IVDR, RE(EU) 2017/746 in December 2022 (Designation number as per NANDO database NB2962) and according to the MDR in May 2024 (Designation number as per NANDO database NB2962). QMD Services is concurrently offering system certification according to EN ISO/IEC 17021-1 for EN ISO 13485 and ISO 9001 where relevant for other models in collaborations with Quality Austria Group.

QMD Services recognizes itself as a European conformity assessment body for in-vitro diagnostics and medical devices and ensures, within its responsibilities, the performance and safety of the respective products through professional assessment processes. In this way we make an active contribution to patient and user safety in Austria as well as internationally and ensure that safe products become available on the European Market.

*Content controlled via QM-00272 Quality Manual 

We ensure medical device safety through professional conformity assessments as Austria’s only designated Notified Body under IVDR and MDR.

QMD Services is an independent third-party conformity assessment body, owned by Quality Austria. Our core-work is to provide certification activities, legally compliant, conforming to standards and performed with a customer-oriented approach. Independence, impartiality and confidentially are fundamental values governing our work.

QMD Services is independent of the manufacturer of any device in relation to which we perform conformity assessment activities. QMD Services maintains also independence of any other economic operator having an interest in the device as well as of any competitors of the manufacturer. This does not preclude us from carrying out conformity assessment activities for competing manufacturers.

We have implemented a structure and processes to safeguard the independence, objectivity and impartiality of our activities throughout our organisation and all individuals involved in conformity assessment activities. Every person working for QMD Services shall uphold the high reputation of QMD Services as notified body and refrain from any actions that could adversely affect the validity of a conformity assessment process and therefore the image of QMD Services. In particular, we make sure that our impartiality is not jeopardised by any commercial, financial or private interests nor by any other pressure.

The foundation of our commitment is to ensure confidence in thorough certification and assessment processes, leading to objective certification decisions focused on patient safety. Our values and the continuous mitigation of impartiality risks play a key role in this process. As part of our quality policy, through top management, QMD Services is committed to ensuring impartiality and collecting, processing and verifying all information, so that our services foster the highest level of trust and positive impact to healthcare.

We guarantee and safeguard the impartiality of the notified body, the top-level management and the assessment personnel. The level of remuneration of the top-level management and assessment personnel of the notified body and of any subcontractors involved in assessment activities does not depend on the results of the assessments.

As CEO and Head of Operations, being responsible for the notified body we publicly declare, that we

  1. do not have any personal interest as in the role as product developer, manufacturer, supplier, installer, purchaser, owner or maintainer of the assessed devices or as authorized representative of one of those parties. Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
  2. are not involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which QMD Services is designated, nor represent the parties engaged in those activities;
  3. do not engage in any activity that may conflict with our independence of judgement or integrity in relation to conformity assessment activities for which QMD Services is designated; in particular, we declare that we are not engaged in any potentially conflicting professional activities, that we do not directly or indirectly hold shares in commercial enterprises in the medical device field, that we are not active in the executive or supervisory boards of any company and that we do not have close personal or family ties to any organization in the field;
  4. do not offer or provide any service which may jeopardise the confidence in our independence, impartiality or objectivity. In particular, we do not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and
  5. are not linked to any organisation which itself provides consultancy services as referred to in point (d). Such restriction does not preclude general training activities that are not client specific and that relate to regulation of devices or to related standards.

Signed:
Anni Koubek, CEO
Florian Heffeter, CEO
Ingrid Blaimauer, Head of Operations

*Content controlled via SOP-00350 Top-level Management Declaration of Interest

We guarantee full independence, impartiality, and transparency in all certification decisions – free from commercial or personal interest.

Member of Team-NB

QMD Services is also a member of Team-NB. Please see their website for further information and documents.

Member of Team-NB

QMD Services is also a member of Team-NB. Please see their website for further information and documents.

Our Team

Behind every conformity assessment at QMD Services is a team of experienced professionals committed to delivering independent, consistent and high-quality evaluations.

Our multinational team combines expertise in clinical medicine, biomedical engineering, natural sciences, medical device development, quality management and regulatory affairs. Based in Austria, with experts located across Europe, we support manufacturers worldwide while applying a harmonised and standardised assessment approach.

Our assessors, technical experts and decision-makers bring extensive practical and regulatory experience across a broad range of medical technologies and risk classes. Supported by a carefully selected network of external expert partners, they work according to clearly defined processes, ensuring consistency, impartiality and regulatory rigour throughout every conformity assessment.

Technical excellence is complemented by a strong commitment to collaboration and communication. We believe manufacturers benefit most when expertise is combined with accessibility, responsiveness and transparent interaction. This enables our teams to work efficiently with clients while maintaining the independence and objectivity expected of a Notified Body.

Want to join our Team?

Our Professional Committement

At QMD Services, our commitment extends beyond conformity assessment. We are dedicated partners to manufacturers who value patient safety, innovation and regulatory excellence. Every project is supported by professionals who combine technical expertise with a practical understanding of the challenges manufacturers face throughout the product lifecycle.

Our multinational team, headquartered in Vienna with an operations office in Linz and European specialists, brings together expertise across clinical medicine, biomedical engineering, natural sciences, medical device development, quality management and regulatory affairs. This multidisciplinary competence enables us to perform thorough, consistent and impartial conformity assessments across a broad range of technologies and risk classes.

Professional excellence is not only reflected in our technical knowledge, but also in the way we work. We believe that expertise should be accompanied by responsiveness, transparency and accountability. From your first interaction with QMD Services, you will work with professionals who communicate clearly, provide reliable guidance and remain accessible throughout the assessment process.

By combining regulatory rigour with a collaborative and service-oriented approach, our teams help create a conformity assessment experience that is efficient, predictable and built on mutual trust – supporting manufacturers in bringing safe, high-quality medical devices and in vitro diagnostics to the European market with confidence.

“At QMD Services, we strive to support medical device innovation, ensuring it is as effective as possible for patients and healthcare professionals, while maintaining the highest levels of quality and regulatory compliance. Every team member supports this by making a dedicated contribution to the process“, says Florian Heffeter, CEO of QMD Services.

A word map showing the countries of our partners and experts.

Why Choose QMD Services?​

For many manufacturers, the greatest challenge today is no longer understanding the regulatory requirements. It is finding a Notified Body that is available, responsive and transparent throughout the conformity assessment process.

At QMD Services, this is exactly what we have built our organisation around. We believe that responsiveness is part of quality. Manufacturers should not face unnecessary waiting periods or uncertainty before their conformity assessment even begins. That is why we focus on providing a structured, predictable and transparent certification experience from the very first contact.

When you choose QMD Services, you can expect:

  • An initial meeting typically scheduled within one week of your enquiry.
  • Immediate preparation of your conformity assessment project following engagement.
  • A dedicated project manager who serves as your consistent point of contact throughout the certification process.
  • Clearly defined timelines and transparent communication, so you always know where your project stands and what comes next.
  • Efficient, standardised assessment processes designed to minimise unnecessary delays while maintaining the highest level of regulatory rigour.

Every manufacturer is different. Different technologies. Different risk classes. Different regulatory challenges. Our experienced assessment teams apply the requirements of the EU MDR, IVDR and ISO 13485 with consistency, precision and impartiality, tailoring the conformity assessment process to the specific characteristics of your devices while maintaining full compliance with regulatory expectations.

Our structured and harmonised approach supports robust technical documentation review, transparent decision-making and reliable certification outcomes. By combining regulatory expertise with efficient project management and clear communication, we help manufacturers navigate conformity assessment with confidence.

Choosing QMD Services means partnering with a Notified Body that values not only regulatory excellence, but also responsiveness, predictability and transparency – helping you bring safe, high-quality medical devices and in vitro diagnostics to the European market with confidence.

Start Your Application Now!
Privacy Settings
We use cookies to enhance your experience while using our website. If you are using our Services via a browser you can restrict, block or remove cookies through your web browser settings. We also use content and scripts from third parties that may use tracking technologies. You can selectively provide your consent below to allow such third party embeds. For complete information about the cookies we use, data we collect and how we process them, please check our Privacy Policy
Save