Medical Devices are critical for the effective treatment of human health-related issues. Patients undergoing any form of treatment should not be adversely affected by medical devices that are used during a treatment which could result in adverse impacts. Medical Devices are therefore regulated by governments through laws and controls. The Medical Devices Rules: 2017, have been notified by the Central Government (Government of India) and have been in effect since 2018. The rules are harmonized with international regulatory practices.

Medical Devices have a classification based on the Risk they may pose on the patient due to the device. The lowest risk devices are classified as A, then B, C, and the most severe risk devices as D. For risk categories A and B, CDSCO has recognized Quality Austria Central Asia as a Notified Body under the Medical Device Rules: 2017. Notified Bodies are nominated by the State Governments to conduct Audits on behalf of the State Licencing Authority, of a particular Medical Device manufacturer and to submit their report and based on the report, the State Government Licencing Authority would issue a certificate. For risk categories C and D, the Central Licencing Authority is responsible, and they do not nominate Notified Bodies to conduct the audit on their behalf. The Notified Bodies would audit the manufacturing covering the following

• • technical review of respective documents as prescribed
• • on-site audit of the manufacturer’s quality management system as laid in the fifth schedule of the Medical Device Rules:2017
• • establish conformity by examination and provision of objective evidence
• • to the essential principles laid down by the Central Government from time to time
• • establish design conformity by reviewing the design documents during
• • assessment of medical devices to ensure their quality, safety, and performance
• • QACA is recognized as a “Semi Regulator” or a Notified Body by CDSCO
• • We are approved via Notification related to MD-2 ie we can grant licenses for the Manufacturing, Sales, Storage, Distribution, and Exhibition of Medical Devices for Class A and Class B
• • QACA will grant a license as per Schedule 4(Plant Medical File ie MD-5) and Schedule 4(as per ISO 13485)
• • Non-measurable and Non-Sterile Devices, No Audit is required(Notified dated 14/10/2022); clients can directly register on the CDSCO Portal and they are granted Licenses.

Medical Device Classifications

The objective of the ISO 13485:2016 internal auditor training course is to help you learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting, and auditing follow-up of an internal audit while maintaining the effectiveness and conformity of an ISO 13485:2016 compliant QMS. In the course, we will cover the general principles of ISO 13485:2016 auditing and walk through all the clauses in this standard, to provide a holistic picture of how audits can be performed.

What You Will Learn?

The ISO 13485:2016 Internal Auditor Training will help you:

• •  Know ISO 13485:2016 structure and scope, as well as how it pertains to organizations seeking regulatory compliance.
• •  Recognize essential auditing principles and auditor responsibilities.
• •  Plan for an internal audit.
• •  Know about general concepts and principles of auditing.
• •  Post-audit activities and CAPA planning.

What You Will Gain Through This Course?

• •  Know the ISO 13485:2016 requirements and the quality system requirements of Directives 93/42/EEC and 98/79/EC.
• •  Have a good understanding of how to conduct internal quality system audits.
• •  Plan and prepare for an internal audit by understanding the function of internal audits in the maintenance and enhancement of management systems.
• •  Collecting information through observation, questioning, and sampling.
• •  Conduct a thorough audit based on identifying, sampling, and questioning processes.
• •  Check to see if corrective action has been taken effectively.

Who Can Attend the ISO 13485:2016 Internal Auditor Training course?

• •  Internal auditors
• •  Consultants
• •  Individuals interested in performing first-party or second-party audits
• •  Management representatives
• •  Medical device quality professionals with expertise in quality management systems and ISO 13485:2016

Pre Requisite

You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management.