ISO 13485 is de internationale norm voor kwaliteitsmanagementsystemen in de medische hulpmiddelenindustrie. Deze norm legt de nadruk op veiligheid, doeltreffendheid en naleving van regelgeving voor bedrijven die betrokken zijn bij het ontwerp, de productie, installatie of het onderhoud van medische hulpmiddelen.
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ISO 13485 Opleidingen
Ontdek op deze pagina een aanbod van opleidingen die zich richten op ISO 13485, dé internationale standaard voor kwaliteitsmanagementsystemen binnen de medische hulpmiddelenindustrie. Deze norm is van cruciaal belang voor organisaties die medische hulpmiddelen ontwerpen, produceren, installeren of onderhouden. ISO 13485 helpt bedrijven om te voldoen aan de strenge wettelijke vereisten en tegelijkertijd de veiligheid en kwaliteit van hun producten te waarborgen.
De opleidingen ISO 13485 zijn ideaal voor kwaliteitsmanagers, compliance officers, interne auditoren, productontwikkelaars en iedereen die betrokken is bij de productie of kwaliteitscontrole van medische hulpmiddelen. Of je nu net start met kwaliteitsmanagement of al ervaring hebt in de sector, er zijn trajecten op maat van elk niveau.
Tijdens deze cursussen leer je onder meer:
- De structuur en inhoud van de ISO 13485-norm begrijpen
- Hoe je een effectief kwaliteitsmanagementsysteem opzet volgens ISO 13485
- Het belang van risicobeheer en documentatie
- De verschillen tussen ISO 13485 en ISO 9001
- Hoe je interne audits uitvoert en voorbereidt op certificatie-audits
- Praktische tools en technieken om compliant te blijven met wetgeving en regelgeving
Veel opleidingen combineren theorie met praktische toepassingen, casestudy’s en oefeningen, zodat je het geleerde onmiddellijk kunt inzetten binnen je organisatie. Daarnaast worden deelnemers vaak begeleid door ervaren docenten uit de sector die je inzicht geven in actuele uitdagingen en best practices.
Met een opleiding ISO 13485 bouw je aan vertrouwen bij klanten en toezichthouders, versterk je je positie in de markt en draag je bij aan de veiligheid van patiënten wereldwijd. Verken nu de beschikbare cursussen en versterk je expertise in kwaliteitsmanagement voor medische hulpmiddelen.
Overzicht cursussen ISO 13485
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
5,5 uur in totaal
Partner: Udemy
Instructeur:
Atlantis Learn
Requirements of ISO 13485.
Wat je leert: Overview of ISO 13485 and its Role , Key Definitions and Terminology , Regulatory Background and Medical Device Industry Regulations
Meer info
Wat je leert: Overview of ISO 13485 and its Role , Key Definitions and Terminology , Regulatory Background and Medical Device Industry Regulations
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
9 uur in totaal
Partner: Udemy
Instructeur:
Natalia Raleva
Master ISO 13485 quality assurance standards for medical devices: system design, documentation, audits, and compliance.
Wat je leert: Understand the full structure, purpose, and scope of ISO 13485 , Apply the key clauses including Quality Management, Resource Management, Product Realization, and Measurement & Improvement , Build and manage compliant documentation including qual
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Wat je leert: Understand the full structure, purpose, and scope of ISO 13485 , Apply the key clauses including Quality Management, Resource Management, Product Realization, and Measurement & Improvement , Build and manage compliant documentation including qual
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
3,5 uur in totaal
Partner: Udemy
Instructeur:
Raul Sempere, The MedTech Academy
A comprehensive review of the international standard for Medical Devices and its application for regulatory compliance..
Wat je leert: Understand what is a Quality Management System and why it is important. , Learn about the Quality Management System requirements applicable to the medical devices industry, under the scope of the international standard ISO 13485:2016. , Understa
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Wat je leert: Understand what is a Quality Management System and why it is important. , Learn about the Quality Management System requirements applicable to the medical devices industry, under the scope of the international standard ISO 13485:2016. , Understa
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
4 uur in totaal
Partner: Udemy
Instructeur:
Dr. Amar Massoud
Downloadable templates and a real world use case.
Wat je leert: Understand the key principles and requirements of ISO 13485 , Learn how to implement ISO 13485 , Gain insight into risk management in medical devices
Meer info
Wat je leert: Understand the key principles and requirements of ISO 13485 , Learn how to implement ISO 13485 , Gain insight into risk management in medical devices
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
70 vragen
Partner: Udemy
Instructeur:
3L Resources
Comprehensive ISO 13485 self-assessment tests to gauge your level of understanding.
Wat je leert: Assess the current level of understanding , Identify improvement or weak areas , Enable further learning of selected areas
Meer info
Wat je leert: Assess the current level of understanding , Identify improvement or weak areas , Enable further learning of selected areas
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
31 minuten totaal
Partner: Udemy
Instructeur:
Waqas Imam
Unlocking the World of Medical Device Quality Management with ISO 13485:2016 QMS standard for life sciences organization.
Wat je leert: Introduction to the ISO 13485 standard. , Understanding the scope of ISO 13485. , Applicability to various organizations within the medical device supply chain.
Meer info
Wat je leert: Introduction to the ISO 13485 standard. , Understanding the scope of ISO 13485. , Applicability to various organizations within the medical device supply chain.
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
1,5 uur in totaal
Partner: Udemy
Instructeur:
Magine Solutions Team
Learn all about ISO 13845 FDA Medical Device Regulation and Quality Management System in this online course.
Wat je leert: Importance of product safety and risk control measures in the complex design and development process for medical devices , Systematic reviews and stages involved in ensuring the success of the design and development process. , Critical role of planning in d
Meer info
Wat je leert: Importance of product safety and risk control measures in the complex design and development process for medical devices , Systematic reviews and stages involved in ensuring the success of the design and development process. , Critical role of planning in d
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
1 uur in totaal
Partner: Udemy
Instructeur:
Magine Solutions Team
Learn all about ISO 13845 FDA Medical Device Regulation and Quality Management System in this online course.
Wat je leert: Definitions of key terms in ISO standards: 'shall,' 'should,' 'may,' and 'can.' , Understanding the mandatory, recommended, permitted, and possible requirements in ISO standards. , Evaluation of medical device manufacturer's quality management systems.
Meer info
Wat je leert: Definitions of key terms in ISO standards: 'shall,' 'should,' 'may,' and 'can.' , Understanding the mandatory, recommended, permitted, and possible requirements in ISO standards. , Evaluation of medical device manufacturer's quality management systems.
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
94 vragen
Partner: Udemy
Instructeur:
Exoexcellence Training Resources
ISO 13485 Practice Exam | Validate QMS Standard knowledge, Medical Devices Regulatory Framework | 4 Audit Case Studies.
Wat je leert: Sample Practice exam for ISO 13485:2016 Lead Auditor Exam , Self Assessment on ISO 13485:2016 Knowledge
Meer info
Wat je leert: Sample Practice exam for ISO 13485:2016 Lead Auditor Exam , Self Assessment on ISO 13485:2016 Knowledge
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
9 uur in totaal
Partner: Udemy
Instructeur:
Petar Dimov
Master ISO 13485: Elevate Medical Device Quality Assurance.
Wat je leert: ISO 13485 Understanding: Gain deep knowledge of ISO 13485 for the medical industry, covering normative references, definitions, and quality management. , Quality Assurance Implementation: Acquire practical skills for implementing quality assurance in medical device manufacturing, ensuring ISO 13485 compli
Meer info
Wat je leert: ISO 13485 Understanding: Gain deep knowledge of ISO 13485 for the medical industry, covering normative references, definitions, and quality management. , Quality Assurance Implementation: Acquire practical skills for implementing quality assurance in medical device manufacturing, ensuring ISO 13485 compli
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
3,5 uur in totaal
Partner: Udemy
Instructeur:
Anil Sharma Kandel
Become an expert in Quality Management system and learn ISO 13485 directly from the standard guidelines..
Wat je leert: Comprehensive course on the ISO 13485 standard for medical device quality management systems , Provides a thorough understanding of the requirements and best practices for implementing and maintaining an ISO 13485 compliant quality management system , 3-hour c
Meer info
Wat je leert: Comprehensive course on the ISO 13485 standard for medical device quality management systems , Provides a thorough understanding of the requirements and best practices for implementing and maintaining an ISO 13485 compliant quality management system , 3-hour c
Doelgroep: Voor beginners..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
2,5 uur in totaal
Partner: Udemy
Instructeur:
Martin Conneely
How to get approval to sell Medical Devices within the European Union. Understand regulatory affairs & ISO 13485 2016.
Wat je leert: Understand how Medical Device Regulation works in the European Union. , Differentiate between a regulation and a directive. , Steps required to gain permission to manufacture and sell a medical device in the European Union.
Meer info
Wat je leert: Understand how Medical Device Regulation works in the European Union. , Differentiate between a regulation and a directive. , Steps required to gain permission to manufacture and sell a medical device in the European Union.
Doelgroep: Voor beginners..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
2 uur in totaal
Partner: Udemy
Instructeur:
Waqas Imam
Design and Development of Medical Devices in the perspective of ISO 13485:2016 and Medical Devices Industry.
Wat je leert: What is ISO 13485:2016? , What is the design and development of a medical device? , What are the steps of design and development of a medical device?
Meer info
Wat je leert: What is ISO 13485:2016? , What is the design and development of a medical device? , What are the steps of design and development of a medical device?
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
1 uur in totaal
Partner: Udemy
Instructeur:
Phaniendra Somraj
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices.
Wat je leert: Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations. , In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility , Create a Process
Meer info
Wat je leert: Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations. , In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility , Create a Process
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
3 uur in totaal
Partner: Udemy
Instructeur:
Waqas Imam
Deep dive into the world of ISO 13485 international standard for medical devices' QMS, basic concepts & requirements.
Wat je leert: Gain a comprehensive understanding of the ISO 13485 standard, its purpose, scope, and how it relates to the quality management system (QMS) for medical devices. , Acquire a solid foundation in the fundamentals of a quality management system, includ
Meer info
Wat je leert: Gain a comprehensive understanding of the ISO 13485 standard, its purpose, scope, and how it relates to the quality management system (QMS) for medical devices. , Acquire a solid foundation in the fundamentals of a quality management system, includ
Doelgroep: Voor beginners..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
1,5 uur in totaal
Partner: Udemy
Instructeur:
Stendard Academy
Awareness and Application for the requirements of ISO 13485:2016 for Medical Device Development and QMS..
Wat je leert: How ISO 13485 requirements apply to medical device companies , Requirements of the ISO 13485:2016 standard , The importance of implementing a Quality Management System per ISO 13485:2016
Meer info
Wat je leert: How ISO 13485 requirements apply to medical device companies , Requirements of the ISO 13485:2016 standard , The importance of implementing a Quality Management System per ISO 13485:2016
Doelgroep: Voor gevorderden..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
1,5 uur in totaal
Partner: Udemy
Instructeur:
Stendard Academy
Successfully conduct an internal audit based on requirements of ISO 13485:2016 for Medical Device Development and QMS.
Wat je leert: Conducting an entire internal audit based on ISO 13485:2016 requirements , General concepts and principles of auditing , Establishing and preparing for the audit
Meer info
Wat je leert: Conducting an entire internal audit based on ISO 13485:2016 requirements , General concepts and principles of auditing , Establishing and preparing for the audit
Doelgroep: Alle niveaus..
Type Opleiding: online/e-learning
Taal: Engels
Duur:
2,5 uur in totaal
Partner: Udemy
Instructeur:
Martin Conneely
Validate a process to gain approval to sell medical devices in the EU, U.S. & Internationally. Compliance to ISO 13485..
Wat je leert: Understand what Process Validation means for any industry. , The course will focus on validation for the life science industry especially the medical device industry. , Understand why we need process validation.
Meer info
Wat je leert: Understand what Process Validation means for any industry. , The course will focus on validation for the life science industry especially the medical device industry. , Understand why we need process validation.