ABOUT US

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

Our Policy – QMD Services

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.
  • 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.

*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

  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

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

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