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This master thesis in Biomedical Sciences, specializing in Quality Assurance, was carried out at Artialis, a company located in the Liege University Hospital compound.
Artialis is a Contract Research Organization (CRO) specialized in the field of musculoskeletal health. The company offers its services to clients of pharmaceutical companies, medical devices in human and animal health, and food supplements companies.
Certified since 2012 with ISO 9001:2008, the first objective of my master thesis is the maintenance of ISO 9001:2015 Quality Management System (QMS) with the participation and preparation of audits. The knowledge of the requirements for this standard is essential for the successful completion of the quality system audits.
In a second phase, the objective is to determine whether the preclinical department could obtain "Good Laboratory Practice (GLP)" certification for its efficacy studies. For this purpose, a feasibility study on the implementation of GLP was undertaken. A gap analysis was conducted to identify gaps between the existing quality system in preclinical and the GLP Principles of the Organization for Economic Cooperation and Development (OECD).
The gap analysis was a long lasting work remotely executed (due to Covid-19) with an internal documentary search and interviews with members of the preclinical department. The results of this analysis were presented to the department direction so she can determine whether the company wanted to head in the certification direction or not.
Eventually, the company was looking for an overview of new potential standards that they could implement in the preclinical department. They were particularly interested by the ISO 10993, Part 6 after having observed its deployment with one of their customers. They requested to study the applicability and advantages in the scope of their business. Mon mémoire de Master en Sciences Biomédicales à finalité spécialisée en Assurance Qualité a été réalisé au sein de la société Artialis, située dans le CHU de Liège.
Artialis est une société de recherche contractuelle spécialisée dans le domaine de la santé musculosquelettique. La société offre ses services aux clients d’entreprises pharmaceutiques, de dispositifs médicaux en santé humaine et animale ainsi qu'aux entreprises de compléments alimentaires.
Certifiée ISO 9001:2008 depuis 2012, le premier objectif de mon mémoire de master consiste au maintien du Système de Management de la Qualité (SMQ) ISO 9001:2015 avec la participation et la préparation aux audits. La connaissance des exigences de cette norme est essentielle pour mener à bien les audits du système qualité en vigueur.
Dans un second temps, l'objectif est de déterminer si le département préclinique pourrait obtenir la certification "Bonnes Pratiques de Laboratoire (BPL)" pour ses études d'efficacité. À cette fin, une étude de faisabilité de l’implémentation des BPL a été entreprise. Une analyse des lacunes a été réalisée pour identifier les écarts entre le système de qualité existant au sein du département préclinique et les principes de BPL de l'Organisation de Coopération et de Développement Économiques (OCDE).
L'analyse des lacunes a été un travail de longue haleine exécuté à distance (en raison du Covid-19) avec une recherche documentaire interne et des entretiens avec les membres du département préclinique. Les résultats de cette analyse ont été présentés à la direction du département afin de déterminer dans quelle direction Artialis souhaitait s'orienter, vers la certification ou non.
Finalement, l'entreprise a cherché à obtenir un aperçu des nouvelles normes potentielles qu'elle pourrait mettre en œuvre dans le département préclinique. Elle était particulièrement intéressée par la partie 6 de la norme ISO 10993, après avoir observé son déploiement chez l'un de ses clients. L’étude de son applicabilité m’a été demandée ainsi que ses avantages dans le cadre de leurs activités.

ISO 9001 --- Quality Management System --- QMS --- Good Laboratory Practice --- GLP --- Sciences de la santé humaine > Multidisciplinaire, généralités & autres

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Brunswick Marine in EMEA (BME) is a subsidiary of one of the largest American boat provider. Their main activities are to receive, store and distribute parts, accessories and boat engines. Our main area of focus for this thesis is the management of quality at BME. The company already has an established Quality Management System (QMS) that is certified to ISO 9001:2008.
In September 2015, a new version of this norm was issued by the writing committee of ISO. Some evolutions and new concepts were added to previous requirements. As a result of this change, companies were given three years to implement new processes and modifications to their QMS. They must go through a transition phase to complete all requirements and receive their new ISO 9001:2015 certificate.
The aim of this project is to propose an optimal transition plan for BME to take the best advantages of this new version of ISO 9001 and succeed their re-certification audit in January 2018. This transition plan will include the timing and adapted solutions to complete all gaps between the new version of the norm and the company’s QMS.
To reach this goal, we started by analyzing in detail the new norm and the system in place at BME to provide a gap analysis specific to the company’s case. Then, we carried out a deep analysis on the major novelties of the standard. We proceeded to develop for each major new concept a detailed definition, their fit in the history and future of quality management and finally we enquired about business best practices to put them into practice. Altogether, we designed for each new requirement an optimal solution based on the analyzed information.
As a result, we concluded that the novelties brought to ISO 9001 can definitely add some value to the company but with an important prerequisite. As we will demonstrate throughout this thesis, the way new concepts will be implemented, incorporated and maintained into the business practices of the company are the key success factors. Benefits will be seen only when all QMS actors accept the new processes and make them part of their daily work.

ISO 9001:2015, new version, transition, certification, Quality Management System. --- Sciences économiques & de gestion > Gestion de l'entreprise & théorie des organisations

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Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. Regulatory technology and data science can lead to new regulatory processes and evidence in the medical field. It can equip stakeholders with unique tools that can make regulatory decisions more objective, efficient, and accurate. This book describes the latest research within the broader domain of Medical Regulatory Technology (MedRegTech). It covers concepts such as the complexity and user-friendliness of medical device regulations, novel algorithms for regulatory navigation, descriptive datasets from a health service provider, regulatory data science techniques, and considerations of the environmental impacts within a national health service. This book brings all these aspects together to offer an introduction into MedRegTech research. In the long term, these technologies and methods will help optimize the regulatory strategy for individual healthcare innovations and revolutionize the way we engage with regulatory services.

Technology: general issues --- History of engineering & technology --- medical technology --- digital healthcare --- data science --- regulations --- machine learning --- software --- medical device regulations --- healthcare provider --- software as medical device --- technology translation --- quality management system --- law --- medical devices --- regulatory data science --- natural language processing --- linguistic analysis --- optimisation --- medical device --- ecodesign --- environmental impact --- classification --- healthcare --- innovation --- regulation --- decision tree complexity --- medical technology --- digital healthcare --- data science --- regulations --- machine learning --- software --- medical device regulations --- healthcare provider --- software as medical device --- technology translation --- quality management system --- law --- medical devices --- regulatory data science --- natural language processing --- linguistic analysis --- optimisation --- medical device --- ecodesign --- environmental impact --- classification --- healthcare --- innovation --- regulation --- decision tree complexity

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Regulations that cover the legal obligations that manufacturers are bound to are essential for keeping the general public safe. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. Regulatory technology and data science can lead to new regulatory processes and evidence in the medical field. It can equip stakeholders with unique tools that can make regulatory decisions more objective, efficient, and accurate. This book describes the latest research within the broader domain of Medical Regulatory Technology (MedRegTech). It covers concepts such as the complexity and user-friendliness of medical device regulations, novel algorithms for regulatory navigation, descriptive datasets from a health service provider, regulatory data science techniques, and considerations of the environmental impacts within a national health service. This book brings all these aspects together to offer an introduction into MedRegTech research. In the long term, these technologies and methods will help optimize the regulatory strategy for individual healthcare innovations and revolutionize the way we engage with regulatory services.

medical technology --- digital healthcare --- data science --- regulations --- machine learning --- software --- medical device regulations --- healthcare provider --- software as medical device --- technology translation --- quality management system --- law --- medical devices --- regulatory data science --- natural language processing --- linguistic analysis --- optimisation --- medical device --- ecodesign --- environmental impact --- classification --- healthcare --- innovation --- regulation --- decision tree complexity --- n/a