Design and verification
For a new device, a design change or a test campaign at an accredited laboratory.
Deliverables
See details →
V&V planTraceability matrixPre-test assessment
Engineering consultant and interim manager, for equipment manufacturers and businesses deploying AI.
Mines Saint-Étienne engineer. Seventeen years across microelectronics, electromedical devices and health software, from electrical engineering to interim quality leadership.
ExperienceSTMicroelectronicsSupersonic ImagineHologicSoftway Medical
IEC 60601-1IEC 60601-1-2IEC 60601-2-37IEC 60601-1-8CISPR 11IEC 61000-4-2ISO 14971IEC 62304IEC 62366-1IEC 81001-5-1IEC TR 60601-4-5ISO/IEC 23894
Two fields, one standard: what gets delivered has to work.
A specific need at the start, a deliverable your team owns at the end.
AEquipment and medical devices
Investigation and lifecycle
For a recurring failure, a component going end-of-life or a change to assess.
Deliverables
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8D reportObsolescence planImpact assessment
Cybersecurity and AI for devices
For connected devices, devices running software or including artificial intelligence functions.
Deliverables
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Threat modelSBOMAI validation report
BBusinesses in every sector
AI and data in business
For a first AI tool, an internal assistant or a data project that has to reach production.
Deliverables
See details →
AI roadmapSecurity memoPolicy and training
Interim management
To replace a technical head, take over a critical project or structure a team.
Deliverables
See details →
First-impressions reportAction planHandover file
Training and coaching
Request a programme →
Tailored: IEC 60601, EMC, failure analysis, AI at work, SPC, lean.
What is coming to your products.
Three EU acts to handle at the design stage.
Data Act
Regulation (EU) 2023/2854
Key dates
- 12 Sept 2025applies
- 12 Sept 2026data access by design
At design stage
- User access to their data in a structured, machine-readable format
- Documented export or access interface
Cyber Resilience Act
Regulation (EU) 2024/2847
Key dates
- 11 Sept 2026vulnerability reporting
- 11 Dec 2027all requirements
At design stage
- Secure by default, reduced attack surface
- SBOM and vulnerability handling for the whole support period
AI Act
Regulation (EU) 2024/1689
Key dates
- 2 Dec 2027high-risk uses (HR, credit…)
- 2 Aug 2028AI in products, incl. medical devices
At design stage
- Automatic event logging
- Measured accuracy, robustness and cybersecurity
Dates as of 23 October 2026. Indicative summary, not legal advice.
Which standards apply to your product or AI project?
Open the tool →
Answer a few questions: the flowchart draws the list of standards and acts likely to apply, from medical devices to business AI tools.
Short, well-scoped engagements your team can take over.
Fixed price or time and materials, remote or on site.
01
Confidentiality
A non-disclosure agreement is signed before any technical exchange.
02
Scoping
Scope, applicable standards, expected deliverable and deadline, agreed in writing.
03
Delivery
Working directly with your R&D, quality and test lab teams.
04
Handover
Deliverable handed over, explained and owned by your team, with no dependency on the consultant.
Julien Martinez, from the cleanroom to leading teams.
Mines Saint-Étienne. Microelectronics, ultrasound imaging, health software: one culture of evidence.
Since March 2025
Softway Medical
Healthcare software group
- Head of Regulatory Affairs2025 →
2018 – 2025
Supersonic Imagine
Ultrasound systems · Hologic group
- Quality and Regulatory Affairs Director2024 – 2025
- Product Compliance, Investigation and Surveillance Manager2023 – 2025
- Senior Manager Sustaining & Electrical Engineering · MOB Manager2020 – 2024
- Quality Assurance Engineer2018 – 2020
2008 – 2018
STMicroelectronics
Semiconductor manufacturing
- Metrology Technical Leader2015 – 2018
- Metrology and Scatterometry Engineer2011 – 2015
- Metrology Apprentice Engineer2008 – 2011
Product certification
IEC 60601, electrical safety, EMC.
Methods
Lean, 8D, SPC, IEC 62304.
Languages
French, fluent English.
A project to move forward? Let's talk.
Three lines are enough: the topic, the stage, the deadline. Reply within two business days.
Use the contact form →LinkedInJulien Martinez ↗
Based inSaint-Maximin-la-Sainte-Baume, France
Please do not send confidential documentation before a non-disclosure agreement has been signed.