Reda Laouar

Background

About Reda Laouar

More than 22 years experience in the Computer Assisted Surgery (CAS) and Surgical Robotics Industry.Mission:Management of a QA/RA experts team whose mission is to ensure the overall quality and regulatory compliance of CAS companies and their medical devices.Experience and Skills- Definition and presentation of regulatory strategies to the companies’ stakeholders- Advice on regulatory requirements- QA/RA coordination of different projects (launch of new products)- Interaction with Competent Authorities during and after audit processes- Direction of submission processes and maintenance of regulatory approvals (FDA, Europe, Australia, Japan, South Korea, Singapore, Malaysia among others)- Management of the construction and maintenance of the DMRs, DHFs and TFs- Coordination of design and development activities for regulatory and quality compliance (i.e. IEC 60601, IEC 62304, IEC 62366, ISO 10993)- Regulatory and Technical support for:* definition of software V/V strategy (including unit testing, integration testing, system-level testing)* definition of system accuracy validation strategy (i.e. ASTM F2554, ASTM F3107)* definition of cybersecurity strategy- Definition of VMP and coordination of special processes validation related to reusable and single use sterile instruments (i.e. ISO 14937, ISO ISO ISO 17665, ISO 17664, ISO 11607, NF S 94-091)- Regulatory support for Clinical Evaluation- Support for the definition of PMS plan (including PMCF) and coordination of data collection for PMS Report- Supervision and coordination of QMS maintenance (i.e. Management reviews, internal audits, CAPA, complaints, control of suppliers, regulatory requirements, etc.)- Direction of the continual adaptation of the QMS to the applicable regulatory requirements (i.e. 93/42/EEC, ISO 13485, ISO 14971, 21 CFR 820, UDI, eMDR among others)- Surveillance of QMS performance results