ISO 13485 MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM - PB Consultancy - ISO Consultant in Ahmedabad

 ISO 13485  MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM


 

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Medical device QMS. A medical device is a product, such as an instrument, machine, implant or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease or other medical conditions. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. 


KEY BENEFITS OF ACHIEVING ISO 13485 CERTIFICATION TO YOUR ORGANIZATION



ISO 13485 REQUIREMENTS

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical device, which strongly focus on the compliance of EU Directives for MD or IVD such as:

ISO 13485 DOCUMENTATION REQUIREMENTS

Here are the documents needed for compliance with ISO 13485:2016



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