ISO 13485 Certification and FDA QMSR Readiness for the Medical Device Industry

Описание: During this webinar we cover: What is ISO 13485?
What Types of Businesses Should Pursue ISO 13485 Certification?
Why Businesses in the Medical Device Industry Should Pursue ISO 13485 Certification
For US businesses - Readiness for FDA QMSR Regulations that go into Effect Feb 2026

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00:00 - [Introduction ]
00:45- [ISO 13485 Webinar Outline]
01:11- [What is ISO 13485]
02:20- [What is a QMS]
05:09 - [Who is ISO]
06:23 - [What Types of Businesses Should Get ISO 13485 Certified]
11:04 - [Why Businesses Should Pursue ISO 13485 Certification]
19:53 - [Regulatory Changes that Affect the Medical Device Industry]
20:30 - [Why is the FDA making changes to Medical Device Regulation]
25:18 - [What is the FDA's Quality Management System Regulation (QMSR)]
27:35 - [How to Implement FDA's QMSR]
32:06- [Q&A and Contact Information]

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If you have questions regarding ISO certification or Quality Management Systems that were not answered in these videos please visit our website or contact us for a free consultation.
https://kellermanconsulting.com/
(800) 535-1376
email: [email protected]

#medicaldevices #iso #iso13485