Albert GUIMFACK

Leading an SaMD MDR 2017/745 compliance workstream: - Continuous improvement of the whole QMS, and particularly for Design&Development and local activities. (ie SOP writing, get alignment with multiple departments, continuous improvement with business feedback) - Ensure proper delivery on Device Vigilance responsibilities and Post Market -Surveillance aspects - Ensure audit CAPAs are implemented. - In coordination with the PO and IT QA, ensure processes are respected for SaMDs and MDR compliance is reached. Implement and track corrective actions if necessary - Continue the evolution of the QMS to enable importation of SaMD out of EU. - Support the discussion with the Legal Manufacturer

Within the framework of the development of an innovative infusion pump Niia Essential developed by the company Pharmasens, I bring my expertise on various aspects: Project management: - Planning design verification, validation and summative phases - Planning follow-up and coordination with the subcontractors Product compliance to IEC 62304 standard - Define the product design verification and validation strategy and approach - Establish software verification plan on system level - Deliverables review (documentation and code)

Expertise with various DM and systems manufacturers in developing and ensuring compliance of their products with the regulatory framework MDR 2017/745, 21 CFR Part11, GxP, BMP: ➢ QARA expertise Preparing and updating technical files for approvals (CE, FDA 510(k) - Ensuring products compliance with current standards (ISO 13485, ISO 14971, ISO 62304, MDR 2017/745, FDA 21 CFR Part 820) - Updating Quality Management System - Manage non-conformities, customer complaints and guarantee product traceability ➢ Test Lead and Quality Design Development of a V&V Master plan for a connected MD – Build an ALM under Jira/Confluence for compliance with IEC 62304. ➢ Project Coordinator Planning of verification, validation and summative phases - Monitoring of the schedule and coordination with subcontractors. ➢ Computerized System validation Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) Execute and oversee the fill validation process Develop and execute Validation Master Plans (VMP), Design Qualification protocols and reports Participate in risks assessments and design reviews

System engineering and scrum master - Risk analysis of the various known defects / bugs inherent in the product and which impact the performance and reliability of the product - Development of a strategy followed by a validation test plan - Implementation of an Agile Scrum approach as part of the development of sub-systems and subcontractors - Management of Design Change, Problem Report - Definition of system requirements and writing of functional specifications Integration and Validation Lead - Writing of technical specifications (hardware and software) - Management and drafting of integration and validation testing procedures (automatic in the form of python and manual scripts) - Verification of the conformity of test results versus specifications

Work closely with software, mechanical, electronic & system engineers to help ensuring the product safety and effectiveness Review product requirements for testability and participate in design discussions Design, write, review, update and execute acceptance and formal verification test protocols Support the Quality team for the analysis & treatment of observed issues Tools used: Python, C++ programming, JIRA, Reqtify, ... Environment: Agile scrum

In this startup, i'm working on development a breakthrough point-of-care in vitro medical device, to quickly and easily assess a person's state of health. So, i'm in charge of several aspects of product development : - Hardware and software development: Choice of subcontractors , components and designs, drafting of specifications documents - Project review animation - Establishment of Technical File for the CE marking by following the 98/79/CE. This makes me also work on standards applied on our device: EN ISO 14971 2013, NF EN 62366, CEI 61010 and NF EN ISO 60304 ...

- Competitive search - Patent search - Software design on matlab - Electronic design and validation

Establishment of Technical File of eye glasses to ensure the appropriate legal compliance with the Medical Devices Directive 93/42/EEC. - Essential requirements, Harmonized standards - Risks analysis according to the standard EN ISO 14971 2013 - Drafting Validation plan IQ - OQ - PQ - Training in usability NF EN 62366

Work on developing a tool for treatment of the EMG signal in order to help health professionnals in diagnosing muscles deseases - Physio-anatomical and biomechanical knowledge of walk - Matlab : Signal processing toolbox and programming - Graphic User Interface (GUI) design

Insurance of the quality control and metrology of the mechanical pieces produced. Validation of the manufacturing processes : - choose and apply the techniques and control methods adapted to each producted piece of small section manufactured in series - Calculations of capabilities and interpretations - Use of method AMDEC for the approach quality within the framework of the reliability of the manufacturing process

- Design and production of medical devices : oxigen concentrator, centrifuge, agitator, autoclave ... - Installation and maintenance of biomedical equipments