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
In 1866, our founders had a bold vision to reduce the impact of technological risks and protect people, assets and the environment. More than 150 years on, sustainability and safety continue to be the backbone of our mission and services.
Our aim is to inspire trust in technology, enabling progress by managing technology-related risks and facilitating change. This commitment is embodied in our claim “Add value. Inspire trust.” We work progressively towards being the trusted partner of choice for safety, security and sustainability solutions, adding tangible value to our clients globally. As we look towards the future, we believe that sustainability and digitalisation will continue to shape the narrative of commerce and society.
Today, we are represented by more than 26,000 employees located across over 1,000 locations. Our community of experts is passionate about technology and is inspired by the possibilities of your business. United by the belief that technology should better people’s lives, we work alongside our customers to anticipate and capitalise on technological developments.
Going beyond regulatory compliance, we inspire trust in a physical and digital world to create a safer and more sustainable future.
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
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
About Coursetakers.ae
Coursetakers.ae is more than a decade old course aggregator and Online course platform that helps students find courses and compare course prices from Training providers in the UAE, by just submitting their inquiry through the website. Coursetakers also helps Institutes, Universities and Online Instructors market their courses, gain leads and get more students to enroll into their courses.
© 2024 www.coursetakers.ae All Rights Reserved. Terms and Conditions of use | Privacy Policy