Pascal Henck Email & Phone Number

Grenoble

Medical device class 3, 62304 safety software classification C

Expertise dans le développement logiciel de dispositifs médicaux (MDR 2017/745)- accompagnement dans la mise en place du cycle de développement logiciel (62304 class C)- analyse de risques logiciels (en lien avec la norme ISO14971)- structuration des exigences, écritures des exigences- structure documentaire et traçabilité pour satisfaire les normes IEC62304 & ISO13485 (outil reqtify)

Région De Villeurbanne, France

Onboard Telecom and Network products

Lyon

Multi tenant application for mobile and WebUse of FHIR specification v4 for interoperabilityMedical device class 1, 62304 class A

Brezins

In charge of creating a new department: build the team (12 FTE: architect, business analyst and testers) and define the system engineering process to define, design, test and deploy the solutions in hospitals (infusion pumps, pump monitoring systems, maintenance tools, HIS interoperability). My team has the following activities:- user senario definition- system requirement elicitation- integration, verification and validation testing activities

Brezins

For embedded software and stand-alone software medical device, I was in charge of- a team composed of PO/project manager, developers and architects (12 FTE) and up to 80 FTE with subcontractors- the software development process including the software risk management for medical device class 2b, 62304 class C, - software design methodology (in-house framework, model based design, UML) in a context of Agile and V cycle development- make or buy decision

Brezins

- As a software project manager, I participated to the development of an enteral pump (Amika), different drug library applications and the parenteral infusion pump (Agilia). In that scope, I was in charge of leading a team (up to 6 people max), delivering the DHF (including the traceability) and writing the system specifications- As an embedded software architect, I defined the HW/SW interface (STM Cortex M3, SafeRTOS) and I participated to the definition of the motor control algorithm (PID controller) for Amika. - As an embedded software architect, I was in charge of the Linux system for the Agilia Link (accessory for the infusion pump) including BSP and drivers (Windriver distribution, iMX27 cpu)- I also developed in Python a requirement tool to manage Office documents so that we can easily create documentation baselines with a structured organisation fitting with the Reqtify projects- I introduced a bug management tool and a configuration management tool (GForge) used by all the software organization

Saint Priest

Client: Renault Trucks, Vehicle dynamics and control systems department (Volvo group)

Région De Strasbourg, France