ISO 13485 Webinars

Webinar designed for organizations that have medical devices that need to be certified according to the EU MDR. This webinar will help you understand the necessary steps that need to be taken, and requirements to be fulfilled, to be fully prepared when the MDR takes full effect (May 2021).

All ISO management standards, together with the IATF 16949 and AS9100 standards, require the use of internal audits as a performance evaluation tool. This webinar will help you answer all your questions and doubts while preparing to perform an internal audit, and give you insights on how to execute it.

Webinar designed for companies that are planning to implement EU MDR and ISO 13485 using the do-it-yourself approach. During this webinar, you will be able to see whether the templates, know-how, and support from Advisera’s 13485Academy are applicable to your implementation project.

The purpose of the webinar is to familiarize the participants with the basics of how to conduct the clinical evaluation.

Webinar designed to familiarize the participants with the basics of risk management for medical device manufacturers, and to explain necessary concepts so that participants know how to implement risk management themselves.

The purpose of this webinar is to help you understand which set of documents needs to be part of technical documentation to provide evidence of a medical device’s safety and performance. Become familiar with how to construct it according to Annex II and Annex III of the EU

The purpose of this webinar is to help you meet the key requirements of your company’s post-market surveillance (PMS) under the EU MDR 2017/745 and explain how to integrate them with the QMS.

Learn how to employ generative AI tools for your ISO implementation

Webinar designed for consultants for ISO 9001, ISO 14001, ISO 27001, and other ISO management standards. The webinar explains how to sell your knowledge in this very competitive market.

Webinar designed for companies that are planning to implement ISO 13485, and don’t have much experience with the standard. This webinar will help you understand what kind of standard ISO 13485 is, what the basic terms are, and what the implementation process looks like.

Webinar designed to familiarize the participants with the basics of the new EU MDR regulation for medical devices, and how ISO 13485 can speed up the compliance process.

Este seminario web está dirigido a auditores internos de ISO 9001, ISO 14001 e ISO 27001, así como otros sistemas de gestión ISO. Este seminario web explica qué diferencias y cambios existen en comparación con una auditoría presencial, pero también trata los riesgos y obstáculos que deben de considerarse, tanto durante la preparación y realización de una auditoría interna en remoto.

Webinar designed for all stakeholders involved in the process of adherence to the European Commission's (EC) In Vitro Diagnostic Regulation (EU IVDR 2017/746) requirements. That includes manufacturers, suppliers, notified bodies, competent authorities, authorised representatives, importers, etc.