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.
To establish a leading independent Conformity Assessment Body for medical devices to advance patient safety and care, as well as optimized patient outcomes, by complying to the MDR/IVDR and by adhering to key principles and standards of medical device vigilance, post market surveillance and device risk management.
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
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 to ensuring confidence are thorough certification and assessment processes and objective 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 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 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 notified body we herewith make this declaration of interest of the executive management publicly available.
Anni Koubek, CEO
Ingrid Blaimauer, Head of Operations
Raymond Nistor, Head Internal Clinician
Good To Know
QMD Services GmbH
1010 Vienna, Austria
Tel.: +43 1 533 0077
Am Winterhafen 1
4020 Linz, Austria
+43 1 5330077