Why ISO 13485 certificate is important for Medical Distributors

For ISO 13485 certification requirements firstly SFDA Saudi Food Drug Authority and USFDA United States Food Drug administration and / or 21 CFR Code of Federal Regulations for Medical devices are applicable. ISO Saudi helps your organisation to

1. confirm design changes were controlled and validated (or where appropriate, verified)
2. determine if design reviews were conducted at appropriate stages of design & development
3. determine if design was correctly transferred to production
4. verify CAPA (Corrective and Preventive Actions) procedures comply with regulatory requirements
5. Verify MDR (Medical device requirements) procedures comply with regulatory requirements
6. verify medical distributors maintains MDR event files that comply with regulatory requirements
7. verify C&R (correction and removal) procedures comply with regulatory requirements

Should you be a Medical device manufacturer, Medical device Distributor and also carry out Medical device servicing in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf and wish to verify compliance to SFDA Saudi Food Drug Authority and USFDA United States Food Drug administration and / or 21 CFR Code of Federal Regulations for Medical devices, ISO 13485 Certification using USFDA approved certifications by approved ISO 13485 global consultants drop email to [email protected]