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Preparing Medical Device File

Technical documentation necessary for the medical device file is described in the Medical device regulation EU MDR 2017/745 in Annex 2 – Technical documentation and EU MDR Annex 3 – Technical documentation for post-market surveillance.

We in our ISO 13485 & MDR Documentation toolkit prepared the obligatory procedures and reports. Other test reports depend on the type of medical device and it was not possible to standardize it. 

On the following link you can see the preview of those documents:

• Procedure for clinical evaluation and related documents https://advisera.com/13485academy/documentation/procedure-for-clinical-evaluation/
• Procedure for post-market surveillance and related documents https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/

• Technical documentation procedure and related documents https://advisera.com/13485academy/documentation/technical-file-procedure/

For more information, see:

• EU MDR 2017/745 in Annex 2 – Technical documentation https://advisera.com/13485academy/mdr/technical-documentation/
• EU MDR Annex 3 – Technical documentation for post-market surveillance https://advisera.com/13485academy/mdr/technical-documentation-on-post-market-surveillance/

• ISO 9001 Pregunta

  El contexto de la organización es un requisito de ISO 9001 en el que se requiere que una organización  considere las cuestiones internas y externas que pueden impactar a sus objetivos estratégicos y a la planificación del SGC. Para cumplir con este requisito, debe de centrarse sólo en las cuestiones que pueden afectar a la satisfacción del cliente y a la entrega de la calidad del producto o servicio.

  El contexto interno tiene que ver con la cultura, las creencias, los valores, o principios dentro de la organización, así como la complejidad de los procesos y la estructura organizativa.

  Por otra parte,el contexto externo está relacionado con cuestiones derivadas del entorno social, tecnológico, ambiental, ético, político, legal, y entorno económico de la organización.

  Para llevar acabo un análisis de este contexto puede realizar un análisis DOFA de debilidades, oportunidades, fortalezas y amenazas o/y un análisis “PEST” (Política, Económico, Social, Tecnológico).

  Respecto a las partes interesadas sólo es necesario identificar aquellas qye tendrán un impacto en la capacidad de la organización para proporcionar productos y servicios para satisfacer constantemente las necesidades del cliente y los requisitos legales. Esto incluye: proveedores, consumidores, uniones de trabajadores, docios, empleados, gobiernos y ONGs, etc.

  Estos materiales pueden ayudarle a entender el contexto de la organización y las partes interesadas:

  - Cómo identificar el contexto de la organización en ISO 9001:2015: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/como-identificar-el-contexto-de-la-organizacion-en-iso-90012015/

  - How to determine interested parties and their requirements accoding to ISO 9001:2015: https://advisera.com/9001academy/blog/2015/11/10/how-to-determine-interested-parties-and-their-requirements-according-to-iso-90012015/

  - Curso gratuito en línea - Fundamentos de la norma ISo 9001:2015:  https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

  - Libro - ISO 9001:2015 through practical examples:  https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

• Difference (implementation-wise) between ISO 13485 and ISO 9001

  There is no difference in the implementation process between ISO 9001 and ISO 13485. Those two standards can run together. However, since ISO 13485:2016 does not have a high level structure as ISO 9001:2015 does, you just need to take into consideration the numbering of the requirements. At the end of the ISO 13485:2016, in Annex B you can find Correspondence between ISO 13485:2016 and ISO 9001:2015. 

  On the following links you can find some useful articles:

  • Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
  • Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

  • Number of procedures required by ISO 13485:2016

    The number of procedures depends on the type of your medical device. Requirements in the standard are prepared for all types of medical devices, so not all requirements are applicable for each medical device. 

    On the following link, you can find the list of mandatory documents from ISO 13485 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

    Of course, if you do not have certain processes (for example sterilization, or your product is not software), then there is no need to prepare and have those documents in your quality management system.

    Furthermore, I would like to point out that these are mandatory documents and definitely some additional documents can be necessary (for example: some policies, organizational charts, some plans and so on). 

  • Generating quality documentation

    1. Can I generate quality documentation and have at least two other people in the R&D group review and approve them?

    Yes, you can generate quality documentation on your situation. Design and development for medical devices have to deal with relevant regulations, product safety, and risk controls on product defects in addition to the usual application requirements, specification requirements, and end-customer needs. 

    Here is the list of mandatory documents from ISO 13485 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

    Of course, if you do not have certain processes (for example sterilization, or your product is not software), then there is no need to prepare and have those documents in your quality management system. 

    The following articles can be helpful:

    • What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
    • How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/

    2. Can Quality Manual be revised as often as needed to reflect our developing stages?

    Yes, the Quality manual can be revised as often as you need. The quality manual must be the reflection of your current state.

    For more information, please see the following links:

    • How to manage the Quality Manual according to ISO 13485:2016 requirements https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/
    • ISO 13485: How to write a short quality manual https://advisera.com/13485academy/knowledgebase/iso-13485-how-to-write-a-short-quality-manual/

    • Is dental software considered as a medical device?

      1. Is dental software considered as a medical device?

      According to the Medical device regulation MDR 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

      • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
      • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
      • the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
      • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations
      • and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

      So if you can define your software within this explanation, then it is a medical device. Each medical device must have the proper classification, and classification is determined by rules The rule that is applicable for software is Rule 11 which states the following:

      Rule 11

      Software intended to provide information which is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:

      • death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or
      • a serious deterioration of a person’s state of health or surgical intervention, in which case it is classified as class IIb.
      • Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.

      All other software is classified as class I.

      For more information, please see the following:

      • EU MDR Annex 8 – classification rules https://advisera.com/13485academy/mdr/classification-rules/

      2. If yes do we need to approach Health Canada for Licensing as a medical device?

      Yes, each medical device, regardless of classification, must be registered in the local authority for medical devices, in your case Health Canada.

    • Questions to check gap analysis to 17025:2017

      All the requirements so the new revision should be checked as audit criteria. If the laboratory is already accredited to ISO 17025:2005, then the major changes in the 2017 version need to be focussed on. For example Clause 8.5 Addressing Risks and Opportunities. Questions must be asked to seek objective evidence. Two example are “Did the laboratory consider risks and opportunities associated with laboratory activities in order to: Give assurance that the management system can achieve its intended results?” and “Does the laboratory plan and take actions to address these risks and opportunities?”

      Your Accreditation Assessment Body would have policies, guidelines and checklists for transition requirements. For example a laboratory would need to ensure that effective implementation of all ISO 17025:2017 requirements have been assessed through the audit programme and gaps closed.

      Have a look at the ISO 17025 document template: Internal Audit Checklist, which is an appendix to the main document, Internal Audit Procedure. The checklist has a list of questions required to ensure the management system is implemented and maintained. It includes more than 100 questions to ensure each requirement of the ISO 17025 standard is implemented and maintained within the Laboratory Quality Management System, and includes the ability for you to add additional questions to suit additional needs. It is available at https://advisera.com/17025academy/documentation/internal-audit-checklist/

    • Queries about ISO 13485

      1. What is the basis of this business and the key point?

      If your question considers the business of producing medical devices, the key point is to ensure the safety and performance of the medical device. The ISO 13485:2016 specifies requirements for a quality management system for organizations involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.technical support).

      2. How to start easiest and how can we understand 13485

      First of all, you need to educate yourself about this standard. You can find some courses about it, find a consultant, and educate yourself with online articles. We recommend that the best start is to read our articles in the ISO 13485 Knowledge database which you can find on the following link: https://advisera.com/13485academy/knowledgebase/ 

      Here I can specify the following articles:

      • What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
      • How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
      • Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
      Furthermore, you can find useful articles on our ISO 13485 Blog: https://advisera.com/13485academy/blog/

      Among all articles on that blog, for starters I can recommend the following articles:

      • ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/
      • How to define roles and responsibilities within an ISO 13485-based QMS https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
      • Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

      3. and how can we apply it completely easiest?

      This depends on how much time and resources you have. You can hire a consultant or you can buy a predefined documentation toolkit where all requirements are already described and your job is to and it is your job to adapt them to your processes, products, people, and more.

      Here is the link to our ISO 13485 Documentation Toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

      Depending on which package you buy, you can get different levels of expert help.

      Here are some more useful articles:

      • How to choose a consultant for ISO 13485 implementation https://advisera.com/13485academy/blog/2019/04/04/how-to-choose-a-consultant-for-iso-13485-implementation/
      • Implementing ISO 13485:2016 with a consultant vs. DIY approach https://info.advisera.com/13485academy/free-download/implementing-iso-13485-2016-with-a-consultant-vs-diy-approach

      • ISO 9001 Presenting Quality System to Top Management

        It seems that the closest thing that we have are these documents: Matrix of Key Performance Indicators; Data Analysis Report and Management Review Minutes. You can find them related with this - Procedure for Management Review - https://advisera.com/9001academy/documentation/procedure-management-review/

        My recommendation is: follow the topics from ISO 9001:2015 clause 9.3.2. Also, put yourself in the shoes of top management: what does top management value more? What is pain for top management? So, show topics about productivity, costs, downtime, complaints, sales, new customers, lost costumers

        You can find more information below:

        • How to make Management Review more useful in the QMS - https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/
        • How to Make Management Review More Practical - https://advisera.com/9001academy/blog/2013/12/10/make-management-review-practical/
        • Free webinar – How to perform management review according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-perform-management-review-according-to-iso-9001-2015-free-webinar-on-demand/
        • ISO 9001 document template: Procedure for Management Review - https://advisera.com/9001academy/documentation/procedure-management-review/
        • Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
        • Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/