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

• In our activities, we focus on safety and performance of medical devices 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 international notified body operations 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.
• We offer our services at European 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.

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 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, Head of Operations and Head Internal Clinician we publicly declare, that we:

a) 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;
b) 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;
c) 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;
d) 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
e) 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 at are not client specific and that relate to regulation of devices or to related standards.

Signed:

Anni Koubek, CEO

Ingrid Blaimauer, Head of Operations

Raymond Nistor, Head Internal Clinician

QMD Services is also a member of Team-NB. Please see their website for further information and documents. Team-NB is organising an online IVDR Technical Documentation Training for Manufacturers on Wednesday June14th. Please contact us for further information if you are interested.