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Our best-selling toolkit ensures that you are able to conform to the leading Quality Management System standard for the medical device industry: ISO 13485.
The toolkit combines documentation templates and checklists that demonstrate how to implement this standard through a step-by-step process. In addition, you can access help from our experts to keep you on the right path, ensuring a straightforward journey to ISO 13485 certification.
If yours is a small company looking to implement a Quality Management System by applying the mandatory documents required by the ISO 13485 standard, as well as documenting the common non-mandatory procedures, then this is the perfect toolkit.
Our leading toolkit provides you with everything necessary to implement both ISO 13485:2016 and EU MDR 2017/745: documentation templates, comprehensive ISO 14971 risk management and sterilization process documentation, and support from our experts.
Along with the essential documents of ISO 13485:2016, the integrated toolkit includes additional commonly used non-mandatory procedures, as well as a more in-depth risk management procedure according to ISO 14971 and the FMEA risk assessment methodology. On top of that, you’ll receive MDR documents like Clinical Evaluation, Post-Market Surveillance, and Technical Maps.
Also included in this toolkit is documentation specific to different sterilization processes. This covers additional sterilization procedures for a variety of sterilization methodologies, such as EtO, steam, dry heat, ionization, and filtration sterilization.
Our EU MDR toolkit guides you on the way to achieving compliance with the MDR and with the following Annexes: Annex I General safety and performance requirements, Annex II Technical documentation, Annex III Technical documentation on post-market surveillance, and Annex XIV Clinical evaluation and post-market clinical follow-up.
The toolkit contains all of the mandatory documents, as well as checklists that guide you to check whether you have prepared all the necessary documentation, so that there are no surprises during the audit conducted by the notifying body.
The toolkit combines documentation templates and checklists that demonstrate evidence of a medical device’s safety and performance.
This toolkit is perfect for you as a starting point for creating technical documentation, and as a guide to all the steps and documents/reports that must be included in the technical documentation in order to prove the safety and performance of your medical device.
This internal audit toolkit will help you conduct an internal audit of your Quality Management System according to the requirements established in the latest version of ISO 13485.
The toolkit contains all mandatory documents needed for the internal audit according to ISO 13485:2016, together with the internal audit procedure, internal audit checklist, and internal audit plan. With everything you need to guide you step by step through the internal audit process, you will be able to conduct an internal audit without hiring external expertise.
This toolkit is perfect for you if you want to focus on internal auditing only, and if you already have other Quality Management System documentation in place.
You know how it works. Developing new policies and procedures from scratch for each of your clients is time consuming. And the more work you need to do, the greater the possibility of missing something. Why not use well-structured templates of all the required documentation, developed by experts, and focus on helping your clients to overcome their real problems with your experience?
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Please do! Click on the “DOWNLOAD FREE TOOLKIT DEMO” button and enter your name and your email address. You can instantly access a free preview of each document template, helping you make up your mind. This is a great chance to see how each document looks, and how easy they are to complete.
Yes. Also, you are entitled to receive free updates of those toolkits for one year after your purchase date.
13485Academy is one of the Academies of Advisera.com. Advisera specializes in helping organizations implement top international standards and frameworks such as EU GDPR, ISO 27001, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO/IEC 17025, AS9100, ISO 20000 and ITIL. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.
Our products are of best-in-class quality. With a proven performance record of successful implementations in more than 100 countries, our world-class customer support ensures success. Read more about the 13485Academy here.
Catherine Nelson