Internal Auditor Training Program on Medical Devices - Quality Management System based on ISO 13485:2016 integrated with EU MDR requirements.

The key to sustained success of any organisation depends on the effective implementation of the Quality Management System and applicable regulatory requirements. Thus, an organisation must stay vigilant in adequately implementing QMS covering applicable requirements like EU MDR. This training program will facilitate the following:

• Assessing the overall context of your organisation and eventually establishing objectives which are in line with business goals
• Consistently provide products/services that meet customer and applicable legal requirements
• Working in a more efficient way which will result in greater productivity and reduce costs
• Expanding into new markets by having an edge over your competitors
• Identifying and addressing risks associated with your organisation

Day 1

Module 1 - ISO 13485:2016 Requirements and integration of EU MDR in QMS for Internal Audits

1. This topic will enable the participants to understand the requirements of ISO 13485:2016, a standalone Quality Management Systems standard for Medical Device manufacturers and mandatory while fulfilling the regulatory compliance

2. Parts of the EU MDR to be considered in IA

3. How to assess the requirements

Day 2

Module 1: Continued

Day 3

Module 2 - Auditing Techniques

4. Auditing techniques

5. Audit planning, Audit Execution and Audit Reporting, based on ISO 19011 Standard

Note: Classroom exercises will be spread across all 3 days

• Medical Device Manufacturing professionals
• Pharmaceutical professionals
• Quality Professionals
• Regulatory Affairs
• Internal and external Auditors
• Consultants and anyone involved with the implementation of the standard & regulator requirements

QMS foundation training or prior knowledge about ISO 13485 standard & basic understanding of EU MDR is desirable. This course is not for filling gaps in the knowledge about the standard; but for enhancing the knowledge about the same with regards to implementation context.

• Expand into new markets by having an edge over your competitors
• Identify and address risks associated with your organization
• Understand how you can better meet regulatory requirements (EU MDR) leading to increased patient safety
• Identify mandatory documented information required by ISO 13485:2016 standard & EU MDR. Develop safe and effective medical devices

1. When can I get the certificate?

Internal Auditor Training Program on Medical Devices - Quality Management System certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the Internal Auditor Training Program on Medical Devices - Quality Management System Program?

• Expand into new markets by having an edge over your competitors
• Identify and address risks associated with your organization
• Understand how you can better meet regulatory requirements (EU MDR) leading to increased patient safety
• Identify mandatory documented information required by ISO 13485:2016 standard & EU MDR. Develop safe and effective medical devices
• Understand internal auditing as per ISO 13485:2016 covering the requirements of EU MDR

5. Is there any refund policy for the paid fees?

Please refer to Cancellation and Refund policy page.