Eddie Byamungu

• As a product distributor, creating internal procedures & working Instructions to meet with regulatory requirements (ISO 13485 and other). • Consult the manufacturer (based in China) on products & shipping, technical file, Contracts, Nonconformances, certificates and set-up meeting with customers

- Set-up the Quality Management System to ISO 13485 and helped with ISO 9001 - Created then trained others on internal Audits, Customer complaints, Changes, CAPAs, SCARs and NCRs, Rework, Training, Management Review and Supplier Process. - Worked with R&D on Risk Management to ISO 14971, IEC 60601, DHF, DHR, DMR & Software Life Cycle 62304 - Participated to the certification Audits ,act as a Subject matter expert on Quality and Supported the legal manufacturer on technical file to IVDR 2017/746

- Set-up the Quality management to ISO13485 & 21 CFR 820/FDA (USA). - Managed/Conducted Internal audits & Supplier audits, customer Complaints, QMS training, Changes, CAPAs, SCARs, Management Review, KPI and Non-Conformities. - Created Technical files to MDR 2017/745 and the Risk Management report to ISO 14971 (including the FMEA) - Liaised with third parties for the 510K registration, for the Cleanroom, for Clinical Evaluation and for Biocompatible.

Updated the Technical files/Documentations for Class IIB Medical devices

- Created the Quality system to ISO 13485 & 21CFR 820(FDA) - Managed Changes, QMS Training, customer complaints, Supplier approval, CAPAs, NCRs and SCARS and feedbacks - Conducted Internal & Supplier Audits and Management review - Worked with R&D on software life cycle IEC62304 report, Risk Management to 14971, DHF, DMR and DHR. - Created the Technical Files for Class I Medical Devices & started transiting to MDR 2017/745. - Participated in Clinical Evaluation Report writing for Class1

- Updated Quality System to ISO 13485 :2012 & Technical files for Class IIa Medical Devices to MDD - Managed Customer Complaints & Feedbacks, Trainings, NCRs, CAPAs, Change Controls and Risk Management to ISO 14971 - Conducted Internal & Supplier Audits and Management Review - Hosted Unannounced & re certification audits from Notified body - Reported Adverse events to the Competent Authorities - Participated in Clinical Evaluation writing for Class IIa/b device

- Maintained the Quality system to ISO 13485, MDD & QSR 21 CFR 820: NCRs, Procedures, Internal Audits, Changes,CAPAs, Customer Complaints & other -Attended Audits from Notified Body,FDA ,Hospira USA & reported Adverse events to Authorities & submitted MDR -Form to FDA - Planned & Conducted Supplier Audits to ISO 9001, 21CFR 820, ISO13485, MDD, IT, write audit Reports, follow-up with suppliers on findings within agreed times.