Improver

Keren Elghouzzi

Senior Software Quality, Digital Health and Regulatory Consultant for Medical Device, CEO at V-Shell Consulting

Israel

. A Software Quality/Regulatory and Software Engineering Process expert with over 20 years of experience in SW industry with Medical Devices Industries, Motorola Israel, Schlumberger France and Airbus Industry .

. Specializes in SW Development, SW Quality and V&V activities for Medical Devices. Expertise in supporting Digital Health companies.

. Provides consultancy and service to companies in all aspects of Software regulations, definition and implementation of Quality Management System, ISO13485, MDSAP, Agile deployment, Software QA/RA, Software V&V, internal Quality Audits.

. Large track record in successful management of both well-established and start-up companies to meet regulatory requirements till certification, including pre-submission and submissions to regulatory authorities (FDA and CE).

. Implementation of IEC 62304 and Sw regulations requirements,
. Performing Sw Risk analysis according to ISO 14971
. Preparing Technical File/DHF for FDA submissions and CE certification

. Design Control management and gap analysis according to IEC62304 and FDA GPSV
. Preparation of Technical Files in accordance to regulatory requirements

. Lecturer at Tel Aviv University on SW Development, IEC62304 for Medical Devices and on Risk Management ,ISO14971 for regulatory courses

. Held several senior positions and managed various Sw QA and Testing Teams within organizations.

. ISO 13485 – certified internal auditor
. SEI-CMM Lead assessor and CMM-I certified assessor - Led Motorola Israel Design Center through SEI CMM Level 5

- A Six Sigma Green Belt and Black Belt trained.
- Holds a BA in Physics and Math and a BSc degree in Electrical Engineering from the Technion specializing in Bio-Med Engineering.

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Experience:

• Firmware Team Leader (Sextant Avionics (French Aerospace subsidiary))
• Sw Testing Research Engineer (Schlumberger)
• Sw Quality and Engineering Process Manager of the entire Design Center (Motorola Solutions)
• Software Testing Manager of the Data Design Center (DDC) division (Motorola Solutions)
• Senior SW QA/RA & Digital Health consultant, CEO and Co-Founder at V-Shell Consulting (VeeShell)
• Head of SW QA/RA & Certification Project Management, SW Quality for Medical Devices (Physio-logic Ltd.)

Skills: