Чеклист документации СМК, соответствующей требованиям MDR, для медицинского программного обеспечения
Воспользуйтесь нашим чеклистом документации Системы Менеджмента Качества (СМК) для производителей медицинского программного обеспечения (MDSW) и проверьте, насколько ваша система управления качеством соответствует MDR.
Документы системы управления качеством необходимы для демонстрации соответствия медицинского программного обеспечения нормативам. Они играют важную роль в сертификации и получении одобрения продукта (CE-маркировки) в ЕС. Поэтому очень важно убедиться, что ваши документы СМК соответствуют требованиям MDR и другим релевантным стандартам, таким как IEC 62304 и IEC 62366.
Документы СМК составляют основу т.н. процесса Оценки Соответствия, который направлен на установление того, что ваш программный продукт соответствует требованиям, предъявляемым в ЕС к такого рода продукции. Документы СМК фиксируют жизненный цикл вашего программного обеспечения. С помощью этих документов вы демонстрируете, что соблюдаете требования, изложенные в MDR, и что ваше медицинское ПО безопасно и может продаваться в ЕС.
Ниже вы найдете чеклист СМК производителя медицинского ПО в соответствии с MDR
Важно: Соответствие MDR и ISO 13485
ISO 13485 является важнейшим стандартом управления качеством в индустрии медицинского оборудования, включая медицинское ПО. Следуя ему, вы добьетесь соблюдения части требований, изложенных в MDR. Но важно понимать, что ISO 13485 не охватывает все аспекты MDR. Существуют особые требования MDR, которые не включены в ISO 13485. Поэтому при разработке СМК необходимо в первую очередь ориентироваться именно на MDR и рассматривать ISO 13485 как вспомогательный инструмент.
Важно: у каждой компании своя уникальная система качества
Каждая компания организует свою СМК, исходя из своих уникальных потребностей. Приведенный ниже чеклист ориентирован на соответствие общим принципам MDR без учета уникальных особенностей каждой организации. В каждом конкретном случае СМК должна быть адаптирована в соответствии с конкретными требованиями вашей компании.
Поскольку разные компании могут иметь свои уникальные процессы и процедуры, наш чеклист содержит раздел (внизу), в который вы можете вручную добавить конкретную документацию, связанную вашими уникальными процессами.
Чеклист СМК производителя медицинского ПО в соответствии с MDR
Заполните поле Компания/Подразделение/Отдел, отметьте флажками имеющиеся документы и поля N/A для требований, неприменимых в вашей ситуации. Распечатайте чеклист или создайте PDF-документ.
ИЛИ
Загрузите шаблон чеклиста в формате Excel и редактируйте его в автономном режиме (изменения внесенные онлайн не отразятся в файле Excel).
Загрузить шаблон чеклиста в формате ExcelЧеклист СМК производителя медицинского ПО в соответствии с MDR
| MDR requirements (Ann. IX, Ch. 1 (2.2)) | Mandatory documents / requirements, ISO 13485 | ISO 13485 ref., docs | Mandatory records, ISO 13485 | ISO 13485 ref., records | N/A | Available |
|---|---|---|---|---|---|---|
| QMS Mandatory Requirements | ||||||
| Manufacturer's quality objectives | Quality objectives | 4.2.1 | N/A | N/A | ||
| Quality manual | 4.2.1, 4.2.2 | N/A | N/A | |||
| Quality policy | 4.2.1 | N/A | N/A | |||
| Organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority | The role(s) undertaken by the organization | 4.1.1 | N/A | N/A | ||
| Responsibilities and authorities | 5.5.1 | N/A | N/A | |||
| Procedure for competence, training and awareness | 6.2 | Records of education, training, skills and experience | 6.2 | |||
| Methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform | Procedure for the validation of the application of computer software | 4.1.6, 7.5.6, 7.6 | Records of software validation activities | 4.1.6, 7.6 | ||
| Procedure for document and record control | 4.2.4, 4.2.5 | Records of product requirements changes | 4.1.6, 7.6 | |||
| Procedure for competence, training and awareness | 6.2 | Records of product requirements changes | 7.2.2 | |||
| Procedure for management review | 5.6.1 | Records of management review | 5.6.1 | |||
| Procedure for internal audit | 8.2.4 | Internal audit plan, Internal audit report | 8.2.4 | |||
| Requirements for the infrastructure | 6.3 | N/A | N/A | |||
| Requirements for the maintenance activities | 6.3 | Records of the maintenance activities | 6.3 | |||
| Procedures for validation of processes | 7.5.6 | Records of the results and conclusion of validation | 7.5.6 | |||
| Procedure for analysis of data | 8.4 | Records of the results of data analyses | 8.4 | |||
| Procedure for monitoring and measuring equipment | 7.6 | Records of the results of calibration and verification of monitoring and measuring equipment | 7.6 | |||
| Where the design, development and/or final verification and testing of MDSW, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party | Written quality agreements with outsource partners | 4.1.5 | Records of the results of evaluation, selection, monitoring and reevaluation of supplier, supplier audit records | 7.4.1 | ||
| Strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of and compliance with conformity assessment procedures | - | - | Records on identification of regulatory and customer requirements | - | ||
| Procedures for identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS and, where opted for, harmonised standards or other adequate solutions into account | - | - | Records on identification of regulatory and customer requirements | - | ||
| Procedures for risk management as referred to in Section 3 of Annex I | Processes for risk management in product realization | 7.1 | Records of risk management activities. Outputs of product realization planning | 7.1 | ||
| Procedures for fulfilling the applicable specific requirements regarding design and construction | - | Records of design | - | |||
| Procedures for clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up | - | - | Clinical evaluation report, PMCF report | - | ||
| Procedures to keep up to date the clinical evaluation plan, taking into account the state of the art. | - | - | Clinical evaluation report, PMCF report | - | ||
| The documentation on the manufacturer’s post-market surveillance system and, where applicable, on the PMCF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92. | - | - | PMS report | - | ||
| Procedures in place to keep up to date the post-market surveillance system, and, where applicable, the PMCF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 87 to 92, as well as the undertaking by the manufacturer to apply those procedures. | - | - | PMS report, PMCF report | - | ||
| Solutions for fulfilling the applicable specific requirements regarding design and construction | Procedure for design and development | 7.3.1 | Design and development planning documents Design and development inputs Design and development outputs Records of design and development review Records of the results and conclusions of the design and development verification Design and development validation plans Records of the results and conclusion of design and development validation Results and conclusions of the design and development transfer Records of the results and actions arising from review of requirements related to product Design and development file | 7.3.2, 7.3.3, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 7.3.7, 7.3.8, 7.2.2, 7.3.10 | ||
| Device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture | - | - | Design and development file | 7.3.10 | ||
| Management of design or quality management system changes | - | - | Records of product requirements changes, Records of design and development changes | 7.2.2, 7.3.9 | ||
| Verification and quality assurance techniques at the release stage | Procedure and methods for the control of release | 4.5.1 | Record for each release Evidence of conformity of products with the acceptance criteria Identity of the person authorizing release of product |
7.5.1 8.2.6 8.2.6 8.2.6 |
||
| Requirements for medical device installation and acceptance criteria for verification of installation | 7.5.3 | Records of medical device installation and verification of installation | 7.5.3 | |||
| Procedure for servicing activities of medical devices | 7.5.4 | Records of servicing activities | 7.5.4 | |||
| Tests and trials which are to be carried out before, during and after release, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment (if applicable). | Procedure for design and development | 7.3.1 | Design and development file | 7.3.10 | ||
| Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29 (art. 10) | Procedure for product identification | 7.5.8 | Product identification records | - | ||
| Procedures for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I | - | - | N/A | 8.2.3 | ||
| Handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders (art. 10) | Procedure for customer feedback gathering | 8.2.1 | Customer feedback report | 8.2.1 | ||
| Procedure for complaint handling | 8.2.2 | Complaint handling records | 8.2.2 | |||
| Procedure for issuing advisory notices | 8.3.3 | Records of actions relating to the issuance of advisory notices | 8.3.3 | |||
| Arrangements for communicating with customers | 7.2.3 | Report to the customer about changes on his property | 7.5.10 | |||
| Processes for reporting of serious incidents and field safety corrective actions in the context of vigilance | - | - | Records of reporting to regulatory authorities | 8.2.3 | ||
| Management of corrective and preventive actions and verification of their effectiveness | Procedure for corrective actions | 8.5.2 | Records of corrective actions | 8.5.2 | ||
| Procedure for preventive actions | 8.5.3 | Records of preventive actions | 8.5.3 | |||
| Software Development Life Cycle (SDLC) Processes (IEC 62304) and Usability design processes (IEC 62366) | ||||||
| Requirement/procedure(s) | Record/document | N/A | Available | |||
| SDLC planning (IEC 62304) | Development plan, MDSW lifecycle plan | |||||
| Usability planning (IEC 62366) | ||||||
| Requirements analysis and management (IEC 62304) | Records on requirements data collection incl. Competitors | |||||
| User requirements elicitation procedure (IEC 62366) | ||||||
| Design and architecture (IEC 62304) | Design specifications based on the requirements | |||||
| Usability specifications procedure (IEC 62366) | ||||||
| User interface design procedure (IEC 62366) | Design specifications, architectural design | |||||
| Coding and implementation procedure (IEC 62304) | Code review records, Engineering records | |||||
| Prototyping and mockup (IEC 62366) | ||||||
| Testing/verification procedure (IEC 62304) | Verification plan, test report | |||||
| Validation procedure (IEC 62304) | Validation plan, validation report | |||||
| Heuristic and task analysis evaluation (IEC 62366) | ||||||
| Usability validation (IEC 62366) | ||||||
| Release management procedure (IEC 62304) | Version release records | |||||
| Quality assurance and review procedure (IEC 62304) | Review, inspection, audit reports | |||||
| Usability testing (IEC 62366) | ||||||
| Change control (IEC 62304) | ||||||
| Change request submission, review, evaluation, impact assessment and approval | Change request, change approval | |||||
| Change Implementation, verification and validation | Change verification plan and report | |||||
| Change communication and notification | Change communication plan and log | |||||
| Rollback procedure | Rollback report | |||||
| Company-specific requirements | ||||||
| Procedures for company-specific processes | Product development, verification, validation and release company specific processes | |||||
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