ISO 13485 Certification
FujiFilms Japan one of the largest conglomerates in Sale, Installation, Service of various types of Medical devices having global presence has signed up with us for the support in ISO 13485 certification.
The process includes preparation of the Medical device file, Validation of software, Ensuring proper Traceability during Sales, Service, Software use, Training on ISO 13485, Compliance to Medical regulatory authorities in Singapore, Malaysia, Philippines, Korea.
Training needs with respect to the Quality management system for medical devices and implementation of the ISO 13485 clauses have been planned to be implemented in a professional approach.
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