Steps for ISO 13485 SFDA Certification
ISO Saudi prepares medical device manufacturers and distributors for ISO 13485 Certification as per SFDA Compliance requirements in Riyadh, Jeddah, Yanbu, Dammam, Jubail, Hofuf. For a Medical device distributor who is into servicing of medical device and where the products are not in warranty the Medical device service provider should implement the following points while designing the service requirements
- Design and development Planning as per ISO 13485
- Design and development Inputs as per ISO 13485
- Design and development Outputs as per ISO 13485
- Design and development Review as per ISO 13485
- Design and development Verification as per ISO 13485
- Design and development Validation as per ISO 13485
- Design and development Transfer as per ISO 13485
- Design and development Changes as per ISO 13485
- Design and development Files as per ISO 13485
The above 9 steps are critical for any Distributors who provide services to medical devices
- ENT
- General Surgery
- Homecare
- Dermatology
- Emergency Medical Services
- Physiotherapy and Rehabilitation
- Sleep Medicine
- Simulation and Audio Visual System
- Respiratory Therapy
For medical device companies located in Dammam, Jubail, Riyadh, Jeddah – Contact [email protected] for more info on ISO 13485 Certification, ISO 13485 Documents, ISO 13485 Distributors, ISO 13485 Servicing