• Over 35 years of broad experience as Engineering professional…Medical Device Safety & Regulatory Engineer, Product Design, Project Management, Quality Management Systems, MDSAP Requirements, Risk Management, Usability Engineering, Standards & Regulations for Medical Devices and Technical Teaching • Medical Device Certifications and Registrations…Device Labeling, Regulatory Submissions, Product Safety Reports per regulatory requirements.• Medical Device Markings/Certifications/Approvals…CE, ISI, FDA 510k, China NMPA, Brazil ANVISA/INMETRO, Safety Marks from various NRTLs, Various Country Approvals/Registrations, Language Requirements• Subject Matter Expert…MDD/MDR-2017, Technical Files, CE Marking; 21CFR – Sub-J, Device Radiation Reports (Initial Reports), Radiation Annual Reports, 510k Filing; India MDR; Standards and Regulations concerning Medical Devices; Device Labeling-Language Requirements; Pre-Market Country Registration of Devices; Quality Systems – 13485/9001 (Certified Lead Auditor); Device Risk Management (ISO 14971); Device Usability Engineering requirements IEC 62366; MDSAP requirements; Application of Standards & Regulations during Design stage of Devices for Compliance;SRE-MEDDEV is the consulting company dealing with Safety and Regulatory aspects of Medical Devices in general.At SRE-MEDDEV, we assist Medical Device Designers/Manufacturers with,•Device Safety Design•CE Marking•US FDA Filing•India Device Registrations•AERB Approvals•Device Safety Certifications from various NRTLs like UL, CSA, TUV, Intertec, etc.•Build Regulatory Strategies•Device Risk Management Files•ISO 13485, ISO 9001, MDSAP Certifications