ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training | South Africa

ISO 13485 | Medical Device Quality Management (MDQMS) | Awareness Training

This introductory one-day awareness training program is centered on ISO 13485:2016, the internationally recognized standard governing quality management systems for medical devices.

Pre-Requisites:

No prior knowledge of the ISO standard or management system is required. A minimum educational level of NQF level 4 (Matric) is recommended.

Learning Outcomes:

• Understand the Purpose and Structure of ISO 13485:2016: Grasp the fundamental purpose and organisational structure outlined in ISO 13485:2016.
• Familiarise with Essential Requirements: Develop familiarity with the essential requirements set forth for medical device manufacturers and suppliers in ISO 13485:2016.
• Recognise Application within Organisational Context: Begin recognising how to apply standard requirements within the specific context of their organisations.
• Identify Necessary Systems and Processes: Identify basic systems and processes necessary for laying the groundwork towards ISO 13485:2016 compliance.
• Appreciate Establishment and Maintenance Considerations: Appreciate foundational strategies for establishing and maintaining basic elements of ISO 13485:2016 compliance within their organisations.
• Introduction to Certification Process: Gain an introductory understanding of the certification process, laying the groundwork for potential future exploration.

Additional Training Details:

Who Should Attend:

• Medical Device Professionals: Individuals engaged in the medical device industry, including manufacturers, distributors, and supply chain participants, will benefit from ISO 13485 awareness training to gain foundational knowledge of the standard's requirements.
• Quality Management Personnel: Professionals responsible for quality management within medical device establishments, involved in planning, implementing, maintaining, supervising, or auditing, can enhance their understanding through ISO 13485 awareness training.
• Compliance and Regulatory Affairs Personnel: Individuals responsible for ensuring compliance with regulatory requirements and managing affairs related to medical device regulations will find ISO 13485 awareness training beneficial.
• Those Seeking Foundational Understanding: Anyone seeking a foundational understanding of ISO 13485:2016, including its scope, structure, and key requirements, will benefit from the awareness training.
• Organisations Pursuing Certification: Entities planning to pursue ISO 13485 certification or seeking license applications, renewals, or amendments can benefit from awareness training to align their practices with the standard's expectations.

Training Formats:

Online Training

We understand the importance of accessibility, especially in the current digital landscape. For virtual participants, our training is conducted online, allowing flexibility from any location. To fully engage in the virtual training, participants are encouraged to ensure uninterrupted internet access throughout the sessions. We recommend having a reliable internet connection and the necessary technology requirements for an immersive and effective online learning experience.

Classroom Amenities:

Classroom training is exclusively conducted at the DQS Academy Office in Boskruin (click here for our address), offering a dedicated and optimal learning environment for all participants.

Participants attending classroom training sessions can enjoy the following amenities:

• Morning Snack: A refreshment to kickstart the day.
• Tea and Coffee: Available throughout the training for participants to stay energised and focused.
• Lunch: A satisfying meal is provided, ensuring participants can recharge and network during the break.

This comprehensive setup aims to create a comfortable and conducive atmosphere, enhancing the overall training experience for all attendees.

Note: If you prefer classroom training, please contact us to request an in-person session that includes the above amenities for a comprehensive learning experience.