Advanced Quality Excellence Ltd

Regulatory and Quality Assurance ComplianceProfessional Regulatory and Quality Assurance Consultant for the Medical Device and Pharma industry. Covers all areas of Quality Management, Technical File Compilation for CE approval and FDA Submissions, transition processes for both ISO 13485 and ISO 9001 developed and implemented, MDD to MDR transitions undertaken. New Product /drug Implementation /submission. Validation (Validation of Processes and Procedures, Cleaning Validation, Cleanroom Validation and Software Validation) IRCA registered Lead Auditor for ISO 13485, ISO 9001, ISO 14001 and ISO 45001 (also OHAS 18001).
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Keywords: hospital & health care