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Quality Management for Medical Devices – ISO 13485:2016

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Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes

This 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: What 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.

Reviews:

 4.5/5

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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 Standard's range of cloud solutions.

$60

Participant(s):

Buy now

Large group ? Request a quote !

This course includes:

One-year 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.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.