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ISO 13485 Training


ISO 13485 is an international standard for medical device manufacturers that outlines the requirements for a quality management system. It is used to ensure that medical devices are safe and effective for their intended use. The standard covers the design, development, production, installation, and servicing of medical devices. Major vendors for this technology include Siemens, Philips, and GE Healthcare. These vendors provide products and services that help medical device manufacturers meet the requirements of ISO 13485. These products and services include quality management systems, risk management systems, and product development processes.

About ISO 13485 Training and Certification Courses


ISO 13485 training and certification courses provide an understanding of the requirements of the ISO 13485 standard and how to implement them in an organization. The courses also provide guidance on how to develop and maintain a quality management system that meets the requirements of the standard.
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Prerequisites for ISO 13485 Certifications


• Understanding of the ISO 13485 standard
• Knowledge of the organization’s quality management system
• Understanding of the organization’s processes and products
• Ability to identify and address non-conformances
• Ability to develop and implement corrective and preventive actions
• Ability to audit the organization’s processes and products
• Ability to develop and maintain records
• Ability to develop and maintain a quality management system

Who should take ISO 13485 Certification Training Courses?


• Quality Managers
• Quality Assurance Professionals
• Quality Auditors
• Quality Engineers
• Quality Consultants
• Medical Device Manufacturers
• Medical Device Suppliers
• Regulatory Affairs Professionals
• Quality System Professionals
• Quality System Managers
ISO 13485 Certification Training Courses are suitable for anyone involved in the medical device industry, including Quality Managers, Quality Assurance Professionals, Quality Auditors, Quality Engineers, Quality Consultants, Medical Device Manufacturers, Medical Device Suppliers, Regulatory Affairs Professionals, Quality System Professionals, and Quality System Managers.

Skills Earned by Individuals after Completing ISO 13485 Training and Certification Courses


1. Understanding of the requirements of ISO 13485:2016
2. Knowledge of the principles of quality management systems
3. Ability to develop and implement a quality management system
4. Ability to identify and address customer requirements
5. Ability to identify and address regulatory requirements
6. Ability to identify and address risk management
7. Ability to identify and address product safety
8. Ability to identify and address product traceability
9. Ability to identify and address product liability
10. Ability to identify and address product recall
11. Ability to identify and address product validation
12. Ability to identify and address product verification
13. Ability to identify and address product design and development
14. Ability to identify and address production and service provision
15. Ability to identify and address post-delivery activities
16. Ability to identify and address nonconforming product
17. Ability to identify and address corrective and preventive action
18. Ability to identify and address internal audits
19. Ability to identify and address management reviews
20. Ability to identify and address continual improvement

Reasons to Choose Koenig Solutions for ISO 13485 Courses


Benefits of Choosing Koenig Solutions for ISO 13485 Training:
• Certified Instructor: Koenig Solutions provides certified instructors to ensure quality training.
• Boost Your Career: ISO 13485 training from Koenig Solutions can help you boost your career.
• Customized Training Programs: Koenig Solutions offers customized training programs to meet the individual needs of the learners.
• Destination Training: Koenig Solutions provides destination training to make learning more convenient.
• Affordable Pricing: Koenig Solutions offers affordable pricing for ISO 13485 training.
• Top Training Institute: Koenig Solutions is one of the top training institutes for ISO 13485 training.
• Flexible Dates: Koenig Solutions offers flexible dates for ISO 13485 training.
• Instructor-Led Online Training: Koenig Solutions provides instructor-led online training for ISO 13485.
• Wide Range of Courses: Koenig Solutions offers a wide range of courses related to ISO 13485.
• Accredited Training: Koenig Solutions provides accredited training for ISO 13485.

Benefits of Taking ISO 13485 Certification Courses


• Improved Quality Management System (QMS): ISO 13485 Certification Training helps organizations to develop and implement a QMS that meets the requirements of the ISO 13485 standard. This helps to improve the quality of products and services, resulting in increased customer satisfaction (90% of customers prefer ISO certified products).
• Cost Savings: ISO 13485 Certification Training helps organizations to reduce costs associated with product recalls, rework, and waste. This can result in cost savings of up to 20%.
• Increased Efficiency: ISO 13485 Certification Training helps organizations to streamline processes and improve efficiency. This can result in increased productivity and improved customer service.
• Improved Compliance: ISO 13485 Certification Training helps organizations to ensure compliance with regulatory requirements. This can help to reduce the risk of fines and penalties.

Ans - No, the published fee includes all applicable taxes.

Yes, you will receive a Certificate of Participation from Koenig Solutions

We accept payments via following methods: • Credit Card • Debit Card • Bank Wire Transfer • We also accept PO from corporate client.

Offer Buy-Now Pay Later if you pay using credit card in US & India It is not available for other countries.

No

You can book online from course page or we will align a Customer Success Manager who will schedule your training.

A laptop, decent internet speed, a Headset with microphone is required.

There are usually 8-10 students in a batch.

Yes, Trainer profile will be shared by the Customer Success Manager

Yes, we will arrange a Tech call with a expert advice for the best courses to help you enter IT.

Even if you are the only participant available, the training will still commence on the scheduled date and time.

We provide digital certificate.

We have our own centres in Dubai, London, New Delhi, Johannesburg, Singapore Gurgaon, Bangalore, Chennai, Goa, New York, Sydney.

Yes, we do offer weekend classes

We do not provide Bank loan facility.

We can provide customized 1-to-1 training for a module as per your requirement.

Yes

If you are not happy with the training and discontinues attending within less than 20% of the duration of the training e.g., by end of first day for a 5-day course