ISO 13485 Certification Quality Management System for Medical Devices

ISO 13485 Certification provides a complete framework for medical device manufacturers, suppliers, or any other external party related to medical devices to ensure product quality and regulatory compliance with the standard.

ISO 13485:2016 Certification is vital for medical device organizations to demonstrate compliance with regulatory requirements so-called law of the land. In the life and health sciences industry, quality management is a multidimensional and non-negotiable issue, covering more than just verification that a finished product meets certain expectations and is safe for use. As a component of the regulatory ISO 13485 standard, a quality management system requires a systematic process for controlling, monitoring, and verifying, analyzing, and improving any activity or process that could affect product conformance. From the manufacturing floor to the end-user the medical devices should be aligned as per the guidelines of the standard. This helps in providing quality products and devices for the consumers.

The International Organization for Standardization (ISO) developed ISO 13485 standard with a revised version in the year 2016 from ISO 13485:2012. Although ISO 13485:2016 standard is based on ISO 9001, (though ISO 13485:2016 is not based on the Annex SL High Level Structure) incorporating the majority of the same requirements, it requires additional controls which include regards to documentation, validation, verification, and identification of regulatory requirements, Increased focus on risk management, Coordination with global regulatory requirements.ISO 13485 Medical Device Quality Management System MDQMS certification focuses on the capability and reliability of your quality, and degree of effectiveness in the areas of design, development, production, and customer care of medical devices and equipment. There is no compromise when it comes to defective devices. The motto of this standard ISO 13485 is to facilitate harmonized quality management system requirements for the medical devices sector.

Improve the credibility of your organization by providing health safety by achieving ISO 13485 Certification. Other benefits are:

1. Improve the process of production
2. Ensures safety in medical devices.
3. Reduces operational cost.
4. Continuous Improvement in medical devices
5. The innate trust of stakeholders and customers
6. Validate customer satisfaction and wellbeing.
7. Encouragement of staff and employee training in medical service providers.
8. Helps in CE Marking of Medical equipment
9. Extensive market access approval

Requirements of ISO 13485 apply to medical devices, the requirements apply equally to associated services as supplied by the organization. ISO 13485:2016 set down requirements for a Quality Management System to medical device equipment and related services such as;

• Identify and adopt a risk management approach to product development and product realization
• Creation of QMS Manual, Processes, Procedures, Formats/Records
• Creation of Medical Device Master File
• Analysis of the validation of processes and procedure
• Compliance with Regulatory requirements and guidelines of the standard
• Proper maintenance, control, and repair of medical devices
• Effective and quick product traceability and recall systems in case of any errors
• Enhancement and continual improvement in technology
• An Internal Audit of the organization

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• We Ascent follow the processes to add value at every stage, by reducing the non-conformities of ISO 13485 Certification.
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