TSY In House Training #665: Understanding ISO 13485:2016 & The FDA 21 CFR Code 820 Training

Training Ongoing.

ISO (International Organisation for Standardisation) is an independent, nongovernmental, international organisation that develops standards to improve the quality, safety, and efficiency of products or services. ISO 13485 is an inter-national standard that outlines the quality standards for organisations that design, develop, and manufacture medical devices. ISO 13485 Medical Devices Quality Management System allows organisations to demonstrate their ability to provide medical devices and related services that consistently meet their customers’ and regulatory requirements.

ISO 13485 Awareness Training gives delegates a broad understanding of the quality management system requirements outlined in the medical devices standard ISO 13485 requirements. ISO 13485 Awareness Training includes exercises to provide delegates with the opportunity to practice the information taught in the course. Our instructors also encourage discussion and debate as part of the learning process.

Date: 19th & 20th November 2024

Venue: Jabil Green Point Precision (M) Sdn Bhd, Sungai Petani, Kedah

Course Objectives:

1. Understand the scope and use of ISO 13485:2016 as basis of Medical Device Regulations

2. Interpret the clauses of ISO 13485:2016 worldwide

3. Differentiate between ISO 13485:2016 and ISO 9001:2015

4. Define ISO 13485:2016 management roles and responsibilities

5. Compare requirements between ISO 13485:2016 and the FDA’s Quality System Regulation

Who Should Attend:

Quality managers, Management Representative, RA managers, Internal Auditors of medical device manufacturing firms, those individuals working in an ISO 13485 compliant environment or in the Medical Devices Industry, Cross functional team members implementing the standard & anyone involved with the implementation of the ISO 13485:2016 standard.

Training Methodology:  

During ISO 13485 Awareness Training the delegate is assessed based on participation and performance through-out the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

More Training Pictures:

Feel free to contact TSY Consultancy by Call / WhatsApp to +6012-6243921 or email to marketing@tsy.my

Cheers.

#TSYConsultancy #ISO13485 #FDA21CFRCode820 #InternalAuditingTraining #MedicalDevices #QualityManagementSystem #GreatFeedback #UsefulandPractical #CertifiedProfessionalTrainer #HRDFClaimable #HRDCorpClaimable #SungaiPetani #Kedah