ISO 13485 Training Courses | ISO 13485 Certification
There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.
An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.
Increasingly, certification to ISO 13485 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.
Our ISO 13485 Training Courses
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QMS Fundamentals based on ISO 13485:2016 Training Course
Language: English
The focus of the Kelmac Group® QMS Fundamentals based on ISO 13485:2016 is to comprehensively introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent and requirements of ISO 13485:2016 plus the business case for adopting ISO 13485:2016
...Duration : 1 Days Course Type : Classroom
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Virtual [VILT] ISO 13485:2016 Lead Auditor Certification Training Course - CQI & IRCA Certified
Language: English
This Virtual [VILT] ISO 13485:2016 Lead Auditor course provides the MD QMS Lead Auditor with the confidence, audit tools and techniques to be able to effectively audit a MD QMS based on ISO 13485:2016 in accordnace with the audit protocol of ISO 19011:2018.
...Duration : 5 Days Course Type : Virtual Price : £1,695.00 per person
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Medical Devices Risk Management Overview based on ISO 14971:2019 Training Course
Language: English
This learning event is aimed at those looking to gain a comprehensive understanding of Medical Device Risk Management based on ISO 14971:2019.
...Duration : 2 Days Course Type : Classroom
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