01
Framing and structuring development
Give your project a development framework that is clear, realistic and proportionate to its technical, clinical and regulatory stakes.
Independent consulting · Technical-regulatory expertise
Securing your medical device's development,
from concept to proof of compliance.
XMD Advisory helps MedTech teams master Design Control : user needs, design requirements, risk management, verification, validation and traceability throughout the development lifecycle.
References:
Science Corporation
·
Pixium Vision
·
Sorin Group
·
30+ years of experience
30+
years of experience
MDR & FDA
dual-market strategy
IEC 62304
medical software
Design Control
R&D systems integration
Expertise
Supporting the key stages of development
From the initial need to proof of compliance, I help your teams structure their decisions, manage risk and produce the right evidence at the right time — in France, across Europe, and on the US market.
1Frame
2Design
3Demonstrate
4Consolidate
02
Turning needs into controlled requirements
Connect user and clinical needs to design requirements that are clear, verifiable and traceable.
03
Managing risk and demonstrating performance
Embed risk management and the verification & validation strategy into design decisions from the very start of the project.
04
Consolidating the file and preparing what's next
Build a coherent set of technical evidence, prepare the transfer, and secure future changes to your medical device.
Support tailored to your situation
Depending on your needs, I step in for a targeted intervention, as temporary reinforcement for an R&D/Quality team, or as senior advisor to project leadership.
Targeted diagnostic
A rapid assessment, identification of gaps, and a prioritized action plan.
Support at a critical milestone
Design review, verification or validation preparation, requirements clarification, traceability consolidation.
Operational reinforcement
Temporary hands-on ownership of Design Control activities, risk management, V&V or technical coordination.
Project support
Ongoing support over several months, from initial structuring through the design file and transfer.
R&D expertise first and foremost
My role is not to add documentation to your project, but to help you make the right design decisions and keep the evidence for them. Drawing on experience with medical devices, systems and software, I help you articulate technical constraints, real-world use, risk management and regulatory expectations into a coherent development approach.
Discuss your project
About
Expertise built on critical medical devices
An engineer by training, I have spent more than 30 years developing complex technology products, most of my career devoted to designing Class III implantable medical devices — defibrillators, pacemakers and visual restoration systems — for the European and US markets.
Today, as an independent consultant, I support MedTech startups and SMEs facing the growing complexity of European (EU MDR/IVDR) and US (FDA) regulations. My R&D technical-regulatory expertise is grounded in real project leadership experience interfacing with QARA and clinical teams. My approach is pragmatic: I pass on applicable methods, not just theory.
Independent — no conflict of interest
Project leadership interfacing with QARA and clinical teams
Available for assignments or training
Based in Le Mans — available in France, across Europe and the UK
Product references
Class III devices, at the intersection of software, systems and clinical practice
These references span interventional rhythmology and visual restoration: active implantable devices, detection and decision algorithms, clinical programmers, follow-up systems, and solutions combining implant, software and user interface. Some historical references are no longer commercialized; they nonetheless illustrate the complex technological and regulatory environments in which I built my Design Control experience.
Defender Range
— ELA Medical
Dual-chamber implantable defibrillator — clinical programming
Historical reference
Contribution: contributed to the development of the programmer software, including a discriminating detection algorithm combining atrial and ventricular information.
Worth noting — in a French multicenter study of 18 patients, the device correctly identified all 122 recorded ventricular tachycardia/fibrillation episodes, as well as 51 of the 53 supraventricular tachyarrhythmia episodes analyzed.
PubMed publication — clinical study ↗
Ovatio DR
— ELA Medical / Sorin Group
Arrhythmia discrimination and reduction of unnecessary ventricular pacing
Historical reference
Contribution: contributed to the programming and clinical follow-up systems for the Ovatio range.
Worth noting — the PARAD+ discrimination algorithm combined with the AAIsafeR 2 pacing mode favored intrinsic conduction; when announcing the first clinical implants in 2005, ELA Medical stated this mode could limit ventricular pacing to 0.1% in patients with normal conduction.
First clinical implants announcement ↗ Clinical review — Europace ↗
Paradym RF
— ELA Medical / Sorin Group
Defibrillation / CRT-D with remote monitoring and resynchronization optimization
Historical range
Contribution: contributed to the programming and clinical follow-up systems for the Paradym RF defibrillators, programmed via Orchestra — the programming system common to the entire range of ELA Medical / Sorin Group implantable defibrillators and pacemakers, and not specific to the Paradym RF range.
Worth noting — RF connectivity for remote monitoring, proprietary SafeR and PARAD+ algorithms; in the SonR CRT-D version, automatic optimization of the atrioventricular and interventricular delays showed improvement in 76% of patients at 12 months, versus 62% in the comparator group.
FDA clearance — BioSpace ↗ RESPOND-CRT / SonR trial ↗Historical range — the Ovatio, Paradym and Paradym RF devices are no longer commercialized under these brands. Orchestra, the programming system common to the entire range of ELA Medical/Sorin Group implantable defibrillators and pacemakers (including the Ovatio and Paradym ranges), is still referenced by MicroPort CRM.
PRIMA
— Pixium Vision / Science Corporation
Visual restoration for patients with AMD
Commercialized in Europe (2026)
Contribution: contributed to the systems and software development of the PRIMA program, initially led by Pixium Vision and continued by Science Corporation, intended for people with geographic atrophy secondary to dry AMD.
Worth noting — a wireless photovoltaic subretinal implant paired with glasses that supply power and data; a study published in the New England Journal of Medicine on 38 participants showed a mean improvement of 25.5 letters on the ETDRS scale at 12 months, with 84% of participants reporting they could read letters, numbers or words.
Clinical study — New England Journal of Medicine ↗ PRIMA study — UPMC ↗ European commercial launch — Science Corporation ↗ Time Magazine cover story — “Computer Chips in Our Bodies Could Be the Future of Medicine” ↗
Contact
Let's talk about your project
Working on a medical device and need regulatory or technical support? I reply to every request within 48 hours.
Email
contact@xmd-advisory.fr
Phone
+33 7 43 77 93 28
Location
Le Mans, Pays de la Loire, France
Available in France, across Europe and the UK
Available in France, across Europe and the UK
Company
XMD Advisory — SASU with capital of €1,000
RCS Le Mans 107 482 721 · Billed on a daily-rate or fixed-fee basis
RCS Le Mans 107 482 721 · Billed on a daily-rate or fixed-fee basis
Guaranteed reply within 48 h