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Ans. – Interested persons can register themselves by visiting our site www.eurotechworld.net and making a payment through any of selected methods.
For more information kindly Call us now for registration at +91-XXX-XXX-XXXX or write to us at info@eurotechworld.net

Ans. – At the end of each course delegates will have enough understanding and knowledge of ISO 13485. Also the delegates will be awarded with “Certificate” on successful completion of course.

Ans. – All the three courses are of different duration as follows.
1. Foundation/ Awareness Course – 1 Day
2. Practitioner Course / ISO 13485 Internal Auditor Course – 2 Days
3. Professional Course/ ISO 13485 Lead Auditor Course – 5 Days

Ans. – There are three types of training provided by Eurotech
1. Foundation/ Awareness Course – Provides an insight into the use of ISO 13485 as the basis for a Quality Management System implemented by medical device manufacturers. Explaining & reviewing the requirements of ISO 13485 and making comparisons to ISO 9001. Participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, Risk Management to Medical Devices.
2. Practitioner Course / ISO 13485 Internal Auditor Course – Internal Auditor ISO 13485 course is intended for medical device quality professionals aiming to enhance their current knowledge of ISO 13485, looking to evaluate and Improve the effectiveness of the quality management system in their organization. Participants will learn the principles and practices of effective quality management system, process audits based on ISO 13485 and ISO 19011. The tutor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions.
3. Professional Course/ ISO 13485Lead Auditor Course – ISO 13485 Medical Devices Lead Auditor course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011. Tutors guide students through the entire audit process, from managing an audit program to reporting on audit results. Course is delivered by means of Power point slides with specific cases form the medical device industry, Group discussion, Group Practices on different topics etc.

Ans. – ISO 13485 Training is useful by various means.
• Understanding and familiarizing with the ISO 13485 principles.
• Understanding the Auditing Principles by following ISO 19011.
• Understanding the Risk in Medical devices by getting awareness of ISO 14971.
• Understanding how to conduct Opening and closing meeting during Audit, Performing Audit, Writing Non conformance and Audit report etc.
• Keeping ourselves updated with updated changes in the standard.
• Understanding the Regulatory requirements.

Ans. – ISO 13485 Training should be attended by:
1. Medical Device Quality Professional looking for implementation of ISO 13485.
2. Professional looking for Internal Auditors profile.
3. Individual professional Consultants
4. Management representatives.

Ans. – ISO 13485 is applicable to all of all the organization into medical devices business, including Manufacturing, Servicing, Installation etc

Ans. – ISO 13485 is a stand-alone QMS for Medical Devices – Quality Management System requirements for regulatory purposes. It is an internationally recognized standard for medical devices manufacturers.