ISO 13485 Webinars

If you are a quality management professional responsible for maintaining or implementing the quality management system for design and manufacture of medical devices, and you are not sure where to begin or how to comply with ISO 13485, our webinars (online trainings) are the perfect solution for you.

Dec
12
2024

How to Construct and Prepare Technical Documentation for Medical Devices Under the EU MDR

Available as: Live webinar, Webinar on demand

Date: Thursday - December 12, 2024

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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

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WEBINARS FOR WHICH ONLY THE RECORDINGS ARE AVAILABLE

Understanding the Process of Clinical Evaluation Under EU MDR for Beginners

Available as: Webinar on demand

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

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How to Perform an Internal Audit Remotely

Available as: Webinar on demand

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Webinar designed for internal auditors for ISO 9001, ISO 14001, ISO 27001, and other ISO management standards. The webinar explains what changes must be made, and what risks and obstacles must be considered during the preparation, performance, and reporting of a remote internal audit.

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Biocompatibility According to the MDR – Where to Start

Available as: Webinar on demand

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Biocompatibility is critical for medical device manufacturers because it ensures that a device can safely interact with human tissues, cells, and bodily fluids without causing adverse effects such as toxicity, allergic reactions, or inflammation. Becoming familiar with crucial steps in the biocompatibility process and how to prepare a testing strategy for medical devices under the MDR is of utmost importance.

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Post-Market Surveillance System According to the EU MDR Requirements

Available as: Webinar on demand

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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.

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ISO 14971:2019 – How to Conduct Risk Management for Medical Devices

Available as: Webinar on demand

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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.

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How to conduct usability engineering under the EU MDR

Available as: Webinar on demand

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Webinar designed for companies and managers who need to conduct usability engineering for medical devices under the European Union Medical Device Regulation. It shows the basics, key factors, and documents needed to become compliant.

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Overview of the Steps Needed to Comply With EU MDR

Available as: Webinar on demand

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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).

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How to Perform an ISO Internal Audit

Available as: Webinar on demand

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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.

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How to Use a Documentation Toolkit for the Implementation of EU MDR & ISO 13485

Available as: Webinar on demand

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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.

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How to use Generative AI Technology for ISO Management Standards

Available as: Webinar on demand

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Learn how to employ generative AI tools for your ISO implementation

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How to Sell ISO Consulting Services

Available as: Webinar on demand

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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.

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A How-to Guide for ISO 13485 Implementation

Available as: Webinar on demand

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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.

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Understanding the new European Medical Device Regulation and how ISO 13485 Supports it

Available as: Webinar on demand

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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.

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Cómo realizar una auditoría interna en remoto [webinar a pedido gratis]

Available as: Webinar on demand

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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.

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What Has Changed in the IVD Industry After EU IVDR – Challenges and Implementation [free webinar on demand]

Available as: Webinar on demand

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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.

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ISO-13485-expert-advisera-round

Kristina Zvonar Brkic
Lead ISO 13485 expert

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