Publicação
Regulation of medical devices to guide the development of a novel wound dressing
| Resumo: | Chronic wounds represent a serious health condition that affects more than 50 million people worldwide, causing a devastating impact on the well-being of the patient as well as a serious problem for the economy. Thus, this work arises from the need to find solutions that can effectively combat this problem. Here is presented a comprehensive study of the regulatory framework of medical devices, focusing on the legal requirements applicable to the development of a novel wound dressing, incorporating antimicrobial agents to treat chronic wounds, named BioMultiDress. The main goal of this thesis was to understand what are the regulatory affairs that need to be considered in order to develop such a medical device. For that purpose, it was made an analysis on the regulations of the regulatory agencies, EMA and FDA, as well as an exhaustive collection of the technical documentation applicable to the BioMultiDress, attending that this device shall be classified as a short-term class III medical device, incorporating ancillary medicinal substances, which in this case are bacteriophages. It was also performed part of the biological evaluation of the BioMultiDress, by the assessment of the bacteriophages cytotoxicity, according to the international standard ISO 10993-5. The studied phages showed no potential cytotoxic effect on BALB 3T3 cells. The knowledge and information herein compiled provides a guide to the medical devices manufacturers and regulatory authorities towards the development of such innovative medical devices as BioMultiDress. To assemble all the information, it was prepared a draft version of the BioMultiDress Design Dossier, containing the main achievements of this work. |
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| Autores principais: | Pereira, Joana Patrícia Ribeiro Aires |
| Assunto: | Chronic wounds Medical devices BioMultiDress Standards Bacteriophages Design dossier Feridas crónicas Dispositivos médicos Normas Bacteriófagos Dossier de design |
| Ano: | 2017 |
| País: | Portugal |
| Tipo de documento: | dissertação de mestrado |
| Tipo de acesso: | acesso aberto |
| Instituição associada: | Universidade do Minho |
| Idioma: | inglês |
| Origem: | RepositóriUM - Universidade do Minho |
| Resumo: | Chronic wounds represent a serious health condition that affects more than 50 million people worldwide, causing a devastating impact on the well-being of the patient as well as a serious problem for the economy. Thus, this work arises from the need to find solutions that can effectively combat this problem. Here is presented a comprehensive study of the regulatory framework of medical devices, focusing on the legal requirements applicable to the development of a novel wound dressing, incorporating antimicrobial agents to treat chronic wounds, named BioMultiDress. The main goal of this thesis was to understand what are the regulatory affairs that need to be considered in order to develop such a medical device. For that purpose, it was made an analysis on the regulations of the regulatory agencies, EMA and FDA, as well as an exhaustive collection of the technical documentation applicable to the BioMultiDress, attending that this device shall be classified as a short-term class III medical device, incorporating ancillary medicinal substances, which in this case are bacteriophages. It was also performed part of the biological evaluation of the BioMultiDress, by the assessment of the bacteriophages cytotoxicity, according to the international standard ISO 10993-5. The studied phages showed no potential cytotoxic effect on BALB 3T3 cells. The knowledge and information herein compiled provides a guide to the medical devices manufacturers and regulatory authorities towards the development of such innovative medical devices as BioMultiDress. To assemble all the information, it was prepared a draft version of the BioMultiDress Design Dossier, containing the main achievements of this work. |
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