MDQMS 13485:2016(MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM)

MDQMS 13485:2016(MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM)

Course Overview :

v The purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.

EligibilityCriteria:-

Some specific Medical Device knowledge and Min. 4 years working experience is required. This is anintensivecourse.

Beforestartingthiscourse,studentsareexpectedtohavethefollowingpriorknowledge:

ISO MDQMS 13485:2016 Course Content

LeadAuditorTraining CourseISO 13485:2016 – Medical Device- QualityManagementSystem

A Third-Party Assessor or Lead Assessor of ISO13485:2016
Responsible for undertaking audits of suppliers/subcontractors as per ISO13485:2016
Responsible for implementing internal audits and audit programs as per ISO 13485:2016
Responsible for implementing the ISO13485 series of standards

Management Systems:

v Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified

MD-QMS ISO 13485:2016, Foundation (FD132) course or equivalent.

•The process approach used in MD-QMS .

• A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.

This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g., MD- QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner – PT219)

• A working knowledge of risk-management principles related to the design of a medical device, for example ISO 14971

Ms.Manimekalai - HSE Adviser | Aim Vision Safety Training & Consulting

t: 044 42140492
m: 91 9047276591
e: training@aimvisionsafety.co.in

#286,First Floor,GST Road,
Chromepet, Chennai 600 044 (Above Vodafone Showroom)

www.aimvisionsafety.co.in
www.isoauditorcourse.in

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