Quality Management for Medical Devices - ISO 13485:2016

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Quality Management for Medical Devices - ISO 13485

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :ย 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

ISO 13485, Medical devices โ€“ Quality management systems โ€“ Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.

This online training also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services

 

Curriculum:

 

Lesson 1: Whats is a medical device ?

 

Lesson 2: What is a quality management system ?

 

Lesson 3: What benefits will it bring to my organization ?

 

Lesson 4: Why was ISO13485 revised ?

 

Lesson 5: What are the key improvements ?

 

Lesson 6: I am certified to ISO 13485:2003, what does it mean for me ?

 

Lesson 7: Relationship with ISO 9001

 

Glossary

 

Evaluation

Author:

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Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager at Merckx, BioDevices and IPSEN.

Reviews:

4.5/5
12
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