ISO 13485 Training


ISO 13485: Awareness training, Medical Devices Training

ISO 13485 Awareness Training

ISO 13485 defines requirements for a Quality management System in respect of medical devices. This standard applies on medical device manufacturers and service providers across the globe and compliance with the standard reflects that manufacturers are concerned about quality.

The awareness training will introduce you with ISO 13485 standard in details. Our tutors will provide you with a brief history of ISO, why the need of ISO 13485 standards arises and what is the importance of this standard. You will get to know about the regulatory requirements applicable on medical devices and services.

Medical Devices Training

We have designed the Medical Devices Training to share knowledge about various aspects covered under ISO 13485. This standard applies to design, development, production, implementation and maintenance of medical devices. Thus, we cover all these parts in our training programme.
The course is designed for top level management and those who are responsible for implementing the standard. Quality managers, regulatory professionals, internal and external auditors can also join this training session. Those who are interested in knowing about the standard and adding them to their business are also welcomed to be a part of this learning process.

The training process will comprise of practical sessions along with theory classes. Our tutors will teach you in line with real-life scenarios. During the training process, you will be given thorough knowledge of ISO 13485 requirements, how to implement them efficiently, planning an approach to fulfill the specifications and integrating business framework with the ISO specifications.

As medical devices and services are meant for the benefit of all, so there should be no compromise with their quality. We are happy to help in maintaining the quality standards.