The 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. ISO 13485:2016 Can Also Be Used By Suppliers Or External Parties That Provide Product, Including Quality Management System-Related Services To Such Organisations. ISO 17664 Specifies Requirements For The Information To Be Provided By The Medical Device Manufacturer For The Processing Of A Medical Device That Requires Cleaning Followed By Disinfection And/Or Sterilisation To Ensure That The Device Is Safe And Effective For Its Intended Use. ISO 10993 Biological Evaluation Of Medical Devices, Evaluation And Testing Within A Risk Management Process, Is The Most Widely Used Standard For Assessing The Biocompatibility Of Medical Devices And Materials, And Provides A Framework For Determining The Appropriate Biocompatibility Steps For Planning A Biological Evaluation. GMP Good Manufacturing Practice (GMP) Is A System For Ensuring That Products Are Consistently Produced And Controlled According To Quality Standards. Also CGMP From FDA USA , GMP Pharmaceuticals, Goods Distribution Practices For Medical Devices ( GDPMD) , Good Storage Practices ( GSP) ,