The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to m
DurationThe ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to medical devices.
Certification to ISO 13485 is not only a requirement of the standard; organizations can reap many benefits from implementing the standard while going through the certification process. The certification process not only opens the doors of EU market for the Organization but it also gives product a quality symbol in the local business.
All ISO standards are reviewed and revised regularly in order to keep it current and relevant for the marketplace. ISO 13485:2016 is latest quality management system standard which is designed to respond to latest technology and regulatory requirements.
Apart from taking up the certification of ISO 13485 for an organization, it is also necessary that each and every employee of the organization understands and follows the Particular standard the importance the basic requirements as stated by the ISO 13485.
That means that the employees of the organization should be given at least the foundation training of the standards so that once the certification is taken it can be maintained within the organization at each and every level. We have developed an in- house course specially aimed at imparting the foundation training of the standard.
During this training, you will be provided an introduction to the standard, including an overview of the purpose and requirements of ISO 13485:2016. Candidates will be helped to understand the intentions behind the revised management system standards. They will also be trained to apply the principles of quality management to an organization.
The course is being delivered by qualified experts and is aimed at anyone who is involved with medical devices and who has responsibility for developing and maintaining a quality management system (QMS).
Who We Are?
We are a leading Total Quality Assurance provider specializing in the field of medical devices industry worldwide. We are one stop solution for inspections, trainings, CE marking, ISO certifications & testing of electrical & electromedical products. We provide customized solutions to help you achieve and effectively maintain your regulatory and commercial success.
About Us
Meddevices Lifesciences Pvt. Ltd is a leading Total Quality Assurance provider specializing in field of medical devices industries worldwide. We are one stops solution for inspections, Trainings, CE marking , ISO certifications & testing of Electrical & electrometrical products; We provide customized solutions to help you achieve and effectively maintain regulatory and commercial success.
We work on PAN India basis with our head office in Ghaziabad; and branches at different locations in India and abroad (EU). We deliver Total Quality Assurance expertise 365 days a year with our industry-winning processes and customer-centric culture.
We can help clients in meeting the quality, health, environmental, safety, and social accountability standards for any market around the world. We have technical experts and QSM approved qualified auditors having extensive global exposure .Our organization holds accreditations, recognitions, and expertise in overcoming regulatory market hurdles.
Meddevices can help you in achieving:
Total Quality Assurance across your supply chain
Rapid & efficient entry to virtually any market in the world
Innovative leadership in meeting social accountability standards
Name and Fame as a trusted and assured brand in the market
Increased Product demand and overall profit
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
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