Awareness Training Program Based on ISO 13485:2016 Standard (Medical Device)
DurationISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system
Your Benefits
This programme will provide participants an insight of the ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).
Outline
Basic Introduction to ISO 13485: 2016
Relation ISO 9001:2015 / ISO 13485:2016
Key issues addressed by ISO 13485:2016
Integration of Risk Management ISO 14971 in ISO 13485
Who Should Attend?
Medical Device Manufacturers.
Quality Professionals
Regulatory Professionals
Internal and external Auditors
Consultants and anyone involved with the implementation of the standard
Prerequisites
Preferred to have basic knowledge in Quality Management system and / or experience if medical device, Pharmaceutical operations.
Certification
Certificate of participation
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This training will introduce the delegates to the knowledge and principles of ISO 13485 which pertains to the quality management system requirement for medical devices.
A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion. This five-day course will empower you to develop necessary expertise for auditing a Quality Management System (QMS) for Medical D
A course participation certificate is provided of 31 CPD (Continuing Professional Development) upon completion. This 5-day course will train you to support implementation and management of Medical Devices Quality Management System (MDQMS) a
A course participation certificate is provided of 14 CPD (Continuing Professional Development) upon completion. The participant will learn different components of an MDQMS (Medical Devices Quality Management System) such as quality manual, r
A course participation certificate is provided of 7 CPD (Continuing Professional Development) upon completion. This training will familiarize you with the basic concepts of implementing and managing Medical Devices Quality Management System
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