ISO 13485 Consulting

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ISO 13485 CERTIFICATION: QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICE INDUSTRIES ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes which is an ISO standard it was published for the first time in 1996 that represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. This standard replaces earlier documents such as EN 46001 and EN 46002 both 1997 the previously published standard were ISO 13485 1996 and 2003 and ISO 13488 also 1996.

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The latest ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

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Such organizations can be involved in one or more stages of the life-cycle including design development production storage distribution installation servicing of a medical device or provision of associated activities e.g. technical support. The standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system.

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ISO 13485 STANDARD BENEFITS:  Increase access to more markets worldwide with certification.  Outline how to review and improve processes across your organization.  Increase efficiency cut costs and monitor supply chain performance.  Demonstrate that you produce safer and more effective medical devices.  Meet regulatory requirements and customer expectations.

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Operon Strategist is ISO 13485 consultant helps to create the documents for ISO 13485 certification. In the first phase Our special screen sharing module helps the client to create that documentation and provide adequate training. This includes the creation of the SOPs work instructions Quality Manuals V M P’s Process Validation documentation etc. In the second phase we provide assistance to implement the system at Shop Floor and provide the need-based training to make sure that the system is adequately implemented. On a routine basis we monitor the system including the Management review meetings Internal quality audits Customer Complaints CAPA Management Handling of Non confirming Products etc. We assist to maintain the complaint system and continual preparedness for the audits.

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Thank You. For More Information Contact Us +91-9325283428

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