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EHS & Regulatory ComplianceRegulatory & Commercial Strategy

Regulatory Affairs and Quality Management

By Speciality Fibres and Materials Ltd

SFM implements and complies with the ISO 13485 (EU, Canada, RoW), 21 CFR 820 (USA) and Ordinance 169 (Japan). We are experts in the overall planning and delivery of regulatory compliance throughout a product’s life cycle. We deliver products CE marked and or FDA cleared. Our Regulatory Affairs and Quality team manage our Integrated QMS.