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Consequences of medical device company not following regulations

In the EU market, it is not possible to place a medical device on the market without previously independent body checks.

In Medical device regulation MDR 20175/745, Article 5 – Placing on the market and putting into service is stated that the device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained, and used in accordance with its intended purpose.

For more information, see:

• EU MDR Article 5 - https://advisera.com/13485academy/mdr/placing-on-the-market-and-putting-into-service/

So, all medical device regards the classification must be in compliance with MDR. Also, a new requirement in the MDR is that Manufacturers of devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.

For further information, see:

• EU MDR Article 10 -  General obligations of manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

The Standard that supports this quality system is ISO 13485:2016

Following articles you may find useful:

• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/
• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/

• Becoming AS9100 expert

  Becoming an expert in AS9100 entails learning about the standard and using it; there is no substitute for experience. The most common way to gain the knowledge of the standard is to take an AS9100 lead auditor training course, which is also attended by certification auditors, as this will also give you insight into what the auditors will look for in an AS9100 QMS. In addition, many people also consider the AS9100 lead certification auditors experts as they see the system implemented in many different aerospace companies. After gaining the training it is critical that you work with the standard to gain a deeper understanding of how it works.

   

  You can learn more about dealing with the experts in the certification audit in the whitepaper: What to expect at the ISO certification audit: What the auditor can and cannot do, https://info.advisera.com/free-download/what-to-expect-at-the-iso-certification-audit

• Integración de calidad, seguridad y medio ambiente

  Desde la última versión de las normas ISO y la adopción de la estructura de alto nivel, donde 10 cláusulas son compartidas , la integración de los sistemas de gestión es mucho más sencilla.

  Para integrar ISO 9001, ISO 14001 e ISO 45001 debes empezar con la determinación del contexto de la organización, cláusula 4, analizando las cuestiones internas y externas, así como las necesidades y expectativas de las partes interesadas. Una vez realizado este paso entonces puede establecer una política del sistema integrado de gestión. 

  La cláusula 4 junto con la cláusula 6 formaría parte del paso de Planificación del ciclo PDCA (por sus siglas en inglés). En este paso deberá identificar los riesgos y oportunidades y abordarlos con las correspondientes acciones. Además en este paso es donde deberá de establecer los objetivos del sistema integrado así como los planes para alcanzarlos.

  Porteriormente, deberá continuar con las cláusulas 7 y 8, que corresponden a la fase de HACER del ciclo PDCA. La cláusula 7 está relacionada con el soporte del sistema de gestión e incluye tanto las competencias, como los recursos y comunicación,  así como el control de la información documentada. Mientras que la cláusula 8 de Operación, es donde más diferencias existen entre las diferentes ISOs. 

  Luego pasaríamos al paso de REVISAR, que correspondería a la cláusula 9 que incluye el seguimiento y medición, auditoría interna y revisión por la dirección. Y finalmente el último paso sería el de ACTUAR, que correspondería a la cláusula 10 de no conformidades y acciones correctivas así como de mejora continua del SIG. 

  Para más información sobre la integración de ISO 9001, ISO 14001 e ISO 45001, vea los siguientes materiales:

  - Artículo - How to integrate ISO 45001 with ISO 9001 and ISO 14001: https://advisera.com/45001academy/blog/2018/09/12/how-to-integrate-iso-45001-with-iso-9001-and-iso-14001/

  - White paper - How to integrate ISO 9001, ISO 14001 and ISO 45001: https://info.advisera.com/9001academy/free-download/how-to-integrate-iso-9001-iso-14001-and-iso-45001

  - Webinar - Cómo integrar ISO 9001:2015 con ISO 14001:2015: https://advisera.com/9001academy/es/webinar/how-to-integrate-iso-90012015-and-iso-140012015-free-webinar-on-demand/

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

  - Curso gratuito en línea - Curso de Fundamentos de la norma ISO 14001:2015: https://advisera.com/training/es/course/curso-fundamentos-iso-14001/

  - Libro - Preparación para el proyecto de implementación ISO: una guía en un lenguaje sencillo: https://advisera.com/books/preparacion-para-el-proyecto-de-implementacion-iso-una-guia-en-un-lenguaje-sencillo/

• Project to implement ISO 27001

  How to propose and sell to our client the project to implement ISO 27001?
  We are ***

  I suggest you use as a basis for your proposal our free template "Project proposal for ISO 27001 / ISO 22301 implementation". You can download a copy at this link: https://info.advisera.com/27001academy/free-download/project-proposal-for-iso-27001-iso-22301-implementation-msword)

  Additionally, you can prepare a presentation based on the template "Project proposal for ISO 27001 implementation". You can download a copy at this link: https://info.advisera.com/27001academy/free-download/project-proposal-for-iso-27001-implementation-powerpoint

  This material is a presentation to show them clearly and succinctly why this project is important for their company.

• Validation Procedure

  No, our pack does not include a Validation procedure. It is covered in the procedure 11_Procedure_for_Production_and_Service_Provision_Premium_EN, under section 3.2.3.

  Since processes that need validation are very different it is not possible to make a uniform procedure for them all. Also, some processes have their own rules and standards on how validation must be performed (eg. each type of the sterilization has its own standard for the validation:

  • ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
  • ISO 11137-1:2006(en) - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

  For more information on validation, you can see the following articles:

  • Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
  • Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

  • ISO 14001 Ciclo de vida de um produto complexo

    Não creio que seja possível estipular uma abordagem standard, cada caso é um caso. Sugiro que para um produto complexo se desenhem círculos de influência e se trabalhe primeiro ao nível dos componentes sobre os quais se tem maior poder ou influência junto de fornecedores ou distribuidores.

    Talvez esta informação seja útil:

    • How does product life cycle influence environmental aspects according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
    • Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
    • Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

  • Lista contatti crm

    Da un punto di vista di stretta compliance, non dovreste usare contatti se non siete certi che tali contatti siano stati acquisiti in modo conforme alle normative sulla privacy previgenti. Infatti, il principio di accountability richiede che il titolare del trattamento sia in grado di dimostrare la conformità. Tuttavia, le Autorità di Controllo sanno perfettamente che il principio di accountability è stato introdotto dal GDPR ed è possibile chiedere il consenso ai clienti e lead presenti nel proprio database. La struttura dell’email dovrebbe essere inversa rispetto a quella indicata nel messaggio.

    Dovreste dire qualcosa del tipo: “Le scriviamo perché in passato è stato in contatto con noi, come cliente o lead, le chiediamo il consenso a contattarla per le seguenti finalità (marketing, newsletter, promozioni, etc., ricordatevi di inserire scopi che effettivamente andrete a raggiungere e non abbondare, perché il Garante non approva che si chieda il consenso per più cose rispetto a quelle che effettivamente si svolgono). Se vuole rimanere in contatto con noi, per favore compili il seguente form. Naturalmente potete personalizzare il messaggio, questo è solo un esempio della struttura.

    L’articolo 12 GDPR, infatti, richiede che ogni informazione data all’interessato del trattamento deve essere data in modo conciso, trasparente, intellegibile e facilmente accessibile, usando un linguaggio chiaro e semplice.” Bisogna anche ottenere il consenso prima di iniziare il trattamento dei dati. Pertanto la struttura è: informazione  consenso  trattamento dati.

    Qui potete trovare alcuni articoli interessanti:

    • Quattro domande principali per ottenere e gestire il consenso degli interessati ai sensi del GDPR https://advisera.com/eugdpracademy/it/knowledgebase/quattro-domande-principali-per-ottenere-e-gestire-il-consenso-degli-interessati-ai-sensi-del-gdpr/
    • Email marketing in the era of GDPR – How to ensure compliance? https://advisera.com/eugdpracademy/blog/2019/05/27/gdpr-and-email-marketing-rules-for-compliant-campaigns/

    Puoi considerare l'iscrizione al nostro corso gratuito:

    • EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//  

    • EU medical device regulation

      From the EU point of view, you do not need to be certified according to the ISO 13485. However, the FDA has in 2018. decide to harmonize and modernize the Quality System Regulations (QSR) under 21 CFR Part 820 to more closely align with the international ISO 13485:2016. This decision was due to the fact that ISO 13485 quality standard forms the basis for quality management system requirements in the European Union, Japan, Canada, and other medical device markets. The latest information that is published is that the FDA plans to issue a notice of proposed rulemaking in October 2020. 

      So, please check regularly FDA page because the final answer is expected at any moment. 

      In the meantime, the following articles can be useful:

      • 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/
      • Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

      If you will need any other assistance with ISO 13485:2016 assistance, please do not hesitate to contact us.

    • ISO 13485:2016 - Complaints Handling

      According to the ISO 13485:2016, section 3 Terms and definitions complaint is written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device or related to a service that affects the performance of such medical devices. 

      Please be careful here with understanding, because sometimes the medical device is service, like installation of service of a medical device in case of some malfunction or break.

      So, information from the customers on late deliveries, wrong billing, and similar can be considered as feedback. 

      For more information regarding customer complaints, please see the following articles:

      • How to comply with ISO 13485:2016 requirements for handling complaints https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
      • Effective complaints management in a QMS https://advisera.com/9001academy/blog/2014/09/16/effective-complaints-management-qms/