Development of an ISO 13485 AND FDA QSR Compliant Quality System for an Academic R&D Group: From Concept to Certification
Notice bibliographique
Résumé
The British Columbia Institute of Technology’s (BCIT) Health Technology Research Group (HTRG) is a team of multidisciplinary researchers that provides medical device development and evaluation services to clients from medical device companies, health care organizations, and academia. Researchers include biomedical engineers, biomechanics and anthropology scientists, plastics, mechanical, electrical, robotics/automation technologists, trades researchers, and industrial designers. In 2000 the HTRG embarked on the development of a quality system that complied with the design and risk management requirements of the U.S. Food and Drug Administration (FDA) Design Controls, Health Canada’s Canadian Medical Device Conformity Assessment System (CMDCAS), and the ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes (ISO 13485). An initial system was developed and launched in 2002. In 2005 we further developed the system to be fully compliant with all requirements of ISO 13485 and obtained certification of the system in 2007. The BCIT HTRG is currently the only ISO 13485 certified academic medical device research group in Canada. The benefits of the quality system for industry clients, students, and the academic research team are discussed as well as the challenges faced in implementing a quality system in an academic research setting. The HTRG has worked with a number of multinational and international companies and would not have been able to attract these clients without operating under a certified system. Our research team is able to shorten the development time from concept to commercialization as prototypes that are developed under a certified quality system can be evaluated in surgical settings. The research staff has been able to access new research funding in part due to the quality system. The major benefit to BCIT’s biomedical and other engineering students is hands-on experience with a working quality system prior to graduation. The challenges associated with introduction and acceptance of a quality system in an academic setting are also discussed along with strategies to increase acceptance of the system. Challenges include overcoming resistance from researchers that perceive quality systems as a constraint on their creativity and as a new administrative burden, managing the costs associated with developing and maintaining a certified quality system, and interfacing with outside departments in an academic environment. Strategies for overcoming these challenges include involving all researchers in the initial development of a system and creating an efficient electronic system that is easily accessed.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».