The vision of QMD Services is quite simple. Everything we do focuses on patient safety. Our independent and impartial medical device experts will bring your innovative medical device technologies to market, provided they are safe and beneficial.
Our Policy – QMD Services
We are experts for certification of medical devices
We are independent, impartial and internationally recognized
We create benefits for patients, users and manufacturers
We are experts from practice
We work with passion and appreciation
*Content controlled via POL-00106 QMD Quality Policy
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 concurrently offering system certification according to EN ISO/IEC 17021-1 for EN ISO 13485 and where relevant for other models in collaborations with Quality Austria Certification GmbH.
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.
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
Signed:
Anni Koubek, CEO
Florian Heffeter, CEO
Ingrid Blaimauer, Head of Operations
*Content controlled via SOP-00350 Top-level Management Declaration of Interest
QMD Services is also a member of Team-NB. Please see their website for further information and documents.