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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 :

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 – Quality management systems – 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:

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:

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Great for pharmaceutical professionals who are interested in ISO 13485. As someone without prior knowledge with medical device or QMS, this is an excellent e-learning content to learn more about ISO 13485. I am looking forward to getting my company onboard with Stendard's range of cloud solutions.

$60

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This course includes:

Full lifetime access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
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Self-paced : access 24/7 to the course during 12 months at your own rhythm.
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