{"id":8280,"date":"2020-09-01T08:53:58","date_gmt":"2020-09-01T08:53:58","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8280"},"modified":"2021-10-04T07:45:19","modified_gmt":"2021-10-04T07:45:19","slug":"fda-software-documentation-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/","title":{"rendered":"\u00a0Documenta\u00e7\u00e3o de software do FDA para dispositivos m\u00e9dicos"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f1aa2bbd8ed\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f1aa2bbd8ed\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#How_to_classify_your_medical_device_software\" title=\"Como classificar seu software de dispositivo m\u00e9dico?\u00a0\">Como classificar seu software de dispositivo m\u00e9dico?\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#FDA_software_documents_for_medical_devices\" title=\"Documentos de software do FDA para dispositivos m\u00e9dicos\">Documentos de software do FDA para dispositivos m\u00e9dicos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#What_are_the_documents_to_be_submitted\" title=\"Quais s\u00e3o os documentos a serem apresentados?\">Quais s\u00e3o os documentos a serem apresentados?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#Description_of_the_documents\" title=\"Descri\u00e7\u00e3o dos documentos\u00a0\">Descri\u00e7\u00e3o dos documentos\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#1_Level_of_Concern\" title=\"1. N\u00edvel de preocupa\u00e7\u00e3o\u00a0\">1. N\u00edvel de preocupa\u00e7\u00e3o\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#2_Software_Description\" title=\"2. Descri\u00e7\u00e3o do software\">2. Descri\u00e7\u00e3o do software<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#3_Device_Hazard_Analysis\" title=\"3. An\u00e1lise de risco do dispositivo\u00a0\">3. An\u00e1lise de risco do dispositivo\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#4_Software_Requirements_Specification\" title=\"4. Especifica\u00e7\u00e3o dos requisitos de software\">4. Especifica\u00e7\u00e3o dos requisitos de software<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#5_Architecture_Design_Chart\" title=\"5. Gr\u00e1fico de projeto de arquitetura\">5. Gr\u00e1fico de projeto de arquitetura<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#6_Software_Design_Specifications_SDS\" title=\"6. Especifica\u00e7\u00f5es de projeto de software (SDS)\">6. Especifica\u00e7\u00f5es de projeto de software (SDS)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#7_Traceability_Analysis\" title=\"7. An\u00e1lise de Rastreabilidade\">7. An\u00e1lise de Rastreabilidade<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#8_Software_Development_Environment_Description_SDED\" title=\"8. Descri\u00e7\u00e3o do ambiente de desenvolvimento de software (SDED)\">8. Descri\u00e7\u00e3o do ambiente de desenvolvimento de software (SDED)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#9_Verification_and_Validation_Documentation\" title=\"9. Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o\">9. Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#10_Revision_Level_History\" title=\"10. Hist\u00f3rico do n\u00edvel de revis\u00e3o\">10. Hist\u00f3rico do n\u00edvel de revis\u00e3o<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/#11_Unresolved_Anomalies\" title=\"11. Anomalias n\u00e3o resolvidas\u00a0\">11. Anomalias n\u00e3o resolvidas\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=FDA-Doc\">redator regulamentar<\/a> Shreya Chenni fornece um guia para a documenta\u00e7\u00e3o de software da FDA para dispositivos m\u00e9dicos, incluindo uma quebra dos requisitos com base na classifica\u00e7\u00e3o.\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">O <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">dispositivo m\u00e9dico<\/a> industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of a biological activity, and improved diagnostic accuracy. Some examples of AI-enabled applications or devices include Arterys Application, Philips WSI and QuantX by Quantitative Insights. The software has to be verified and validated, to ensure its safety and effectiveness.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para qualquer dispositivo que contenha software que passe pelo <a href=\"https:\/\/www.kolabtree.com\/blog\/13-mistakes-to-avoid-in-a-510k-submission-for-quick-fda-clearance\/\">rota 510(k)<\/a>Os documentos espec\u00edficos relacionados a software t\u00eam que ser apresentados. Neste artigo, discutimos os documentos necess\u00e1rios para <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/510-k-submissions\">510(k) submiss\u00f5es<\/a> e entender como esbo\u00e7\u00e1-los com base na classifica\u00e7\u00e3o de seu software.\u00a0\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_classify_your_medical_device_software\"><\/span><b>Como classificar seu software de dispositivo m\u00e9dico?\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Identificar o N\u00edvel de Preocupa\u00e7\u00e3o aplic\u00e1vel (LoC). H\u00e1 tr\u00eas n\u00edveis:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Maior: uma falha ou falha latente pode resultar diretamente em morte ou ferimento grave do paciente ou operador\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">OU\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0uma falha ou falha latente pode resultar indiretamente na morte ou ferimento grave do paciente ou operador atrav\u00e9s de informa\u00e7\u00f5es incorretas ou atrasadas ou atrav\u00e9s da a\u00e7\u00e3o de um prestador de cuidados.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Moderado: uma falha ou falha de projeto latente pode resultar diretamente em les\u00f5es menores ao paciente ou ao operador<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u00a0OU\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">uma falha ou falha latente pode resultar indiretamente em les\u00f5es menores ao paciente ou ao operador atrav\u00e9s de informa\u00e7\u00f5es incorretas ou atrasadas ou atrav\u00e9s da a\u00e7\u00e3o de um prestador de cuidados.\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Menor: se falhas ou falhas de projeto latentes s\u00e3o improv\u00e1veis de causar qualquer dano ao paciente ou ao operador.\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Use a Tabela 1 e a Tabela 2 do <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">Orienta\u00e7\u00e3o da FDA para o Conte\u00fado de Envios Pr\u00e9-mercados de Software Contido em Dispositivos M\u00e9dicos<\/span><\/a><span style=\"font-weight: 400;\"> para responder \u00e0s perguntas e determinar seu N\u00edvel de Preocupa\u00e7\u00e3o com o Software.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"FDA_software_documents_for_medical_devices\"><\/span><b>Documentos de software do FDA para dispositivos m\u00e9dicos<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"What_are_the_documents_to_be_submitted\"><\/span><span style=\"font-weight: 400;\">Quais s\u00e3o os documentos a serem apresentados?<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Softwares de n\u00edvel moderado e de grande preocupa\u00e7\u00e3o t\u00eam 11 documentos diferentes a serem apresentados. J\u00e1 os softwares de menor n\u00edvel de preocupa\u00e7\u00e3o requerem sete documentos diferentes. O escopo e a extens\u00e3o dos detalhes nesses documentos varia com base em seu LoC.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A tabela a seguir identifica os documentos necess\u00e1rios para cada um dos n\u00edveis de preocupa\u00e7\u00e3o:\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Menor<\/b><\/td>\n<td><b>Moderado<\/b><\/td>\n<td><b>Major<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">N\u00edvel de preocupa\u00e7\u00e3o<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u00edvel de preocupa\u00e7\u00e3o<\/span><\/td>\n<td><span style=\"font-weight: 400;\">N\u00edvel de preocupa\u00e7\u00e3o<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Descri\u00e7\u00e3o do software<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Descri\u00e7\u00e3o do software<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Descri\u00e7\u00e3o do software<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de risco do dispositivo<\/span><\/td>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de risco do dispositivo<\/span><\/td>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de risco do dispositivo<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Especifica\u00e7\u00e3o de requisitos de software (SRS)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Especifica\u00e7\u00e3o de requisitos de software (SRS)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Especifica\u00e7\u00e3o de requisitos de software (SRS)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de Rastreabilidade<\/span><\/td>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de Rastreabilidade<\/span><\/td>\n<td><span style=\"font-weight: 400;\">An\u00e1lise de Rastreabilidade<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Hist\u00f3rico do n\u00edvel de revis\u00e3o\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Hist\u00f3rico do n\u00edvel de revis\u00e3o\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Hist\u00f3rico do n\u00edvel de revis\u00e3o\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Gr\u00e1fico de projeto de arquitetura<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Gr\u00e1fico de projeto de arquitetura<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Documento de especifica\u00e7\u00e3o de projeto de software<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Documento de especifica\u00e7\u00e3o de projeto de software<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Descri\u00e7\u00e3o do Ambiente de Desenvolvimento de Software\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Descri\u00e7\u00e3o do Ambiente de Desenvolvimento de Software\u00a0<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">&#8212;&#8212;&#8212;&#8212;<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Anomalias n\u00e3o resolvidas (Bugs ou Defeitos)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Anomalias n\u00e3o resolvidas (Bugs ou Defeitos)<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Description_of_the_documents\"><\/span><b>Descri\u00e7\u00e3o dos documentos\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"1_Level_of_Concern\"><\/span><b>1. N\u00edvel de preocupa\u00e7\u00e3o\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Registrar as respostas \u00e0s perguntas da Tabela 1 e da Tabela 2 do <\/span><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">Orienta\u00e7\u00e3o da FDA para o Conte\u00fado de Envios Pr\u00e9-mercados de Software Contido em Dispositivos M\u00e9dicos<\/span><\/a><span style=\"font-weight: 400;\">\u00a0 neste documento. Incluir uma fundamenta\u00e7\u00e3o para o determinado n\u00edvel de preocupa\u00e7\u00e3o.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"2_Software_Description\"><\/span><b>2. Descri\u00e7\u00e3o do software<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Este documento apresenta o software do dispositivo e, portanto, deve fornecer uma vis\u00e3o abrangente das caracter\u00edsticas, funcionalidades, uso pretendido. Incluir linguagem de programa\u00e7\u00e3o, plataforma de hardware, sistema operacional e uso de software Off-the-Shelf conforme aplic\u00e1vel. Figuras e diagramas devem ser inclu\u00eddos conforme apropriado.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Caso o dispositivo utilize software Off-the-Shelf, consulte o documento de orienta\u00e7\u00e3o da FDA\".<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/shelf-software-use-medical-devices\">Orienta\u00e7\u00e3o para o uso de software fora da prateleira em dispositivos m\u00e9dicos<\/a>.\u201d\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"3_Device_Hazard_Analysis\"><\/span><b>3. An\u00e1lise de risco do dispositivo\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0Uma an\u00e1lise de risco do dispositivo \u00e9 uma obriga\u00e7\u00e3o. Todos os perigos previs\u00edveis associados ao uso pretendido do dispositivo (software e hardware) devem ser capturados. A an\u00e1lise de risco deve ser conduzida em conformidade com a ISO 14971. A an\u00e1lise de perigo deve identificar o perigo, perigo, gravidade do perigo, causa do perigo, medida de controle de risco e verifica\u00e7\u00e3o da medida de controle.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"4_Software_Requirements_Specification\"><\/span><b>4. Especifica\u00e7\u00e3o dos requisitos de software<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">A Especifica\u00e7\u00e3o de Requisitos do Software (SRS) documenta todos os requisitos para o software. Basicamente, os requisitos descrevem o que o software deve fazer. Os requisitos podem ser colocados em diferentes baldes, tais como funcionais, de desempenho, de interface de usu\u00e1rio e regulamentares.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para LoC menores, o SRS pode ser um resumo dos requisitos funcionais, por\u00e9m, para os moderados e maiores, os requisitos t\u00eam de ser detalhados e tipicamente listados. Certifique-se de que cada requisito listado tenha um ID de requisito atribu\u00eddo a ele, como SRS-01, SRS-02 e assim por diante.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Aqui est\u00e3o alguns exemplos da SRS:\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Requisitos de hardware: Incluir os requisitos sobre -\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> microprocessadores\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> dispositivos de mem\u00f3ria<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> sensores\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> fontes de energia\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> caracter\u00edsticas de seguran\u00e7a<\/span><\/li>\n<li><span style=\"font-weight: 400;\"> comunica\u00e7\u00f5es<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Requisitos de programa\u00e7\u00e3o: Incluir os requisitos de tamanho do programa, restri\u00e7\u00f5es, etc.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Requisitos de interface: Incluir requisitos que descrevem a comunica\u00e7\u00e3o entre o software e os dispositivos de hardware, tais como impressoras, monitores. Outros requisitos, como o sistema operacional com o qual o software \u00e9 compat\u00edvel e assim por diante.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Desempenho do software e requisitos funcionais O desempenho do software e os requisitos funcionais incluem algoritmos ou caracter\u00edsticas de controle para terapia, diagn\u00f3stico, monitoramento, alarmes, an\u00e1lise e interpreta\u00e7\u00e3o com refer\u00eancias de texto completo ou dados cl\u00ednicos de suporte, se necess\u00e1rio.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O desempenho do software e os requisitos funcionais tamb\u00e9m podem incluir:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Limita\u00e7\u00f5es do dispositivo devido ao software\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Testes e verifica\u00e7\u00f5es internas de software<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Tratamento de erros e interrup\u00e7\u00f5es\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Caracter\u00edsticas de detec\u00e7\u00e3o de falhas, toler\u00e2ncia e recupera\u00e7\u00e3o 12 Cont\u00e9m recomenda\u00e7\u00f5es n\u00e3o vinculativas\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Exig\u00eancias de seguran\u00e7a<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Requisitos de tempo e mem\u00f3ria\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identifica\u00e7\u00e3o de software pronto para uso, se apropriado.\u00a0<\/span><\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"5_Architecture_Design_Chart\"><\/span><b>5. Gr\u00e1fico de projeto de arquitetura<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00a0Este documento apresenta claramente a rela\u00e7\u00e3o, fluxo de dados e intera\u00e7\u00e3o entre os principais componentes ou blocos funcionais do software. Isto \u00e9 normalmente retratado na forma de fluxograma, diagramas de blocos e outras formas, conforme apropriado. Para software de n\u00edvel moderado e de maior preocupa\u00e7\u00e3o, o diagrama de projeto pode incluir diagramas de estado.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"6_Software_Design_Specifications_SDS\"><\/span><b>6. Especifica\u00e7\u00f5es de projeto de software (SDS)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">A implementa\u00e7\u00e3o dos requisitos est\u00e1 detalhada neste documento. Cada SDS deve ser numerado, tal como o SDS-01, semelhante ao SRS. Cada exig\u00eancia inclu\u00edda na SRS deve ter uma especifica\u00e7\u00e3o de projeto correspondente. Entretanto, tamb\u00e9m \u00e9 poss\u00edvel que uma \u00fanica especifica\u00e7\u00e3o de projeto possa corresponder a um grupo de requisitos.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"7_Traceability_Analysis\"><\/span><b>7. An\u00e1lise de Rastreabilidade<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Este documento vincula os requisitos, especifica\u00e7\u00f5es de projeto, perigos e testes de V&amp;V. A matriz de rastreabilidade pode ser elaborada conforme abaixo, detalhes podem ser acrescentados conforme apropriado:\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400;\">Necessidade do usu\u00e1rio (opcional)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Perigos<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Casos de teste V&amp;V<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Haz-001<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-001<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">UND-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SRS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">SDS-001<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SDS-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Haz-002<\/span><\/td>\n<td><span style=\"font-weight: 400;\">TC-002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">TC-004<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"8_Software_Development_Environment_Description_SDED\"><\/span><b>8. Descri\u00e7\u00e3o do ambiente de desenvolvimento de software (SDED)<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">\u00c9 necess\u00e1rio um software moderado e de alto n\u00edvel de preocupa\u00e7\u00e3o para apresentar um SDED que descreva o plano do ciclo de vida de desenvolvimento de software, manuten\u00e7\u00e3o e atividades de software. O n\u00edvel de detalhamento difere para Moderado e Major. Consulte a EN 62304 Tabela 1: Tabela A.1 - Resumo dos requisitos por classe de seguran\u00e7a de software. Isto pode ser usado para identificar os elementos a serem inclu\u00eddos e as atividades que devem ser documentadas por sua classe. As tr\u00eas classes A, B e C est\u00e3o alinhadas com o n\u00edvel de preocupa\u00e7\u00e3o da FDA.\u00a0<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"9_Verification_and_Validation_Documentation\"><\/span><b>9. Documenta\u00e7\u00e3o de Verifica\u00e7\u00e3o e Valida\u00e7\u00e3o<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">LoC Menor: Teste de n\u00edvel do dispositivo de documento e teste de integra\u00e7\u00e3o (se aplic\u00e1vel). Assegurar que os casos de teste tenham um crit\u00e9rio de aceita\u00e7\u00e3o e um resumo dos resultados do teste.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">LoC moderado: Lista resumida de documentos de valida\u00e7\u00e3o e verifica\u00e7\u00e3o de atividades e seus resultados. Incluir crit\u00e9rios de aceita\u00e7\u00e3o. Garantir que a An\u00e1lise de Rastreabilidade fa\u00e7a refer\u00eancia a IDs de casos de teste.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Major LoC: Al\u00e9m das informa\u00e7\u00f5es acima (LoC Moderado), a descri\u00e7\u00e3o de quaisquer testes fracassados e as mudan\u00e7as feitas em resposta a eles devem ser documentadas.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"10_Revision_Level_History\"><\/span><b>10. Hist\u00f3rico do n\u00edvel de revis\u00e3o<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Documentar as principais mudan\u00e7as no software, assegurando que a \u00faltima linha tempo\/entrada seja a \u00faltima vers\u00e3o do software. Identificar o n\u00famero da vers\u00e3o, data e descrever as mudan\u00e7as em rela\u00e7\u00e3o \u00e0 vers\u00e3o anterior.\u00a0<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"11_Unresolved_Anomalies\"><\/span><b>11. Anomalias n\u00e3o resolvidas\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Documentar os bugs n\u00e3o resolvidos existentes no software que est\u00e1 sendo lan\u00e7ado. Capture o seguinte para cada bug:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">O problema<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Impacto no desempenho do dispositivo\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Cronogramas planejados para corrigir estes erros (se aplic\u00e1vel)\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Os onze documentos acima cobrem toda a documenta\u00e7\u00e3o necess\u00e1ria para o software do dispositivo. Al\u00e9m disso, a FDA exige Documenta\u00e7\u00e3o de Seguran\u00e7a Cibern\u00e9tica, como plano de seguran\u00e7a cibern\u00e9tica, gerenciamento de risco e testes V&amp;V e seus resultados. Para mais informa\u00e7\u00f5es sobre estas diretrizes da FDA sobre requisitos de Ciberseguran\u00e7a, consulte: <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/content-premarket-submissions-management-cybersecurity-medical-devices\"><span style=\"font-weight: 400;\">Conte\u00fado das Submiss\u00f5es Premarket para Gerenciamento de Seguran\u00e7a Cibern\u00e9tica em Dispositivos M\u00e9dicos<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Refer\u00eancias:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.fda.gov\/media\/73065\/download\"><span style=\"font-weight: 400;\">Orienta\u00e7\u00e3o para o Conte\u00fado de Envios Pr\u00e9-mercados de Software Contido em Dispositivos M\u00e9dicos<\/span><\/a><\/li>\n<\/ul>\n<blockquote><p><strong>Precisa de ajuda com a documenta\u00e7\u00e3o do software da FDA para dispositivos m\u00e9dicos? Entre em contato com os redatores freelance de regulamenta\u00e7\u00e3o e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions\">Especialistas em apresenta\u00e7\u00e3o da FDA<\/a> em Kolabtree.<\/strong><\/p><\/blockquote>","protected":false},"excerpt":{"rendered":"<p>Freelance regulatory writer Shreya Chenni provides a guide to FDA software documentation for medical devices, including a breakdown of the requirements based on classification.\u00a0 The medical device industry is seeing rapid technological advancement and a high rate of innovation.\u00a0 Nowadays, many devices are AI-enabled, which allows early detection of disease, identification of different patterns of<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/fda-software-documentation-for-medical-devices\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":8292,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - 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