We've gathered all the common ISO 13485 questions about Certification together with expert answers.
Download the Free e-Book for the answers to 26 questions.
Here, we at deGRANDSON Training, a provider of ISO 13485 training, have assembled a comprehensive set of ISO 13485 Certification FAQS...
The Questions Answered
- What is ISO?
- What is ISO 13485?
- What is the purpose of ISO 13485?
- What is a Medical Device Management System (MDMS)?
- What is the Purpose of a Medical Device Management System?
- Who Needs a Medical Device Management System?
- What are the Benefits of a Medical Device Management System?
- What is ISO 13485 Certification?
- Do You Need ISO 13485 Certification?
- Who needs ISO 13485 Certification?
- Does ISO 13485 Certification require the services of a Notified Body?
- What are the Benefits of ISO 13485 Certification?
- Is ISO 13485 Feedback the same as ISO 9001 Customer Satisfaction?
- Why does ISO 13485 call for documentation many times while ISO 9001 does not?
- Is ISO 13485 intended for Medical Device Manufacturers only?
- Do applicable regulatory requirements mentioned in ISO 13485 include ISO 14971 and other ISO Standards?
- How much does ISO 13485 Certification Cost?
- Who issues ISO 134851 Certification Certificates?
- How to get an ISO 13485 Certificate
- How to Choose a Certification Body?
- Are online ISO 13485 Certificates you can get within 30 days legitimate?
- Why is it Important to Get Certified by the Proper Certification Body?
- How does the ISO 13485 Certification Process Go?
- How to check the ISO 13485 Certification of an organization?
- Do Management Representatives or others responsible for an MDMS need training?
- Do Internal Auditors need training?
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