Hire the Best Medical Devices Specialists
in Canada

Many hardware startups waste months and tens of thousands of dollars building the wrong prototype. I help founders define the right hardware architecture before building the prototype, so the first version of the product actually validates the idea. My work focuses on the early stages of hardware product development, where a few key technical decisions shape the entire project. Instead of jumping straight into PCB design, I help clarify the system architecture, identify technical risks, and define the fastest path toward a functional prototype. As a licensed Professional Engineer in Québec, Canada (OIQ), I specialize in turning early product ideas into clear technical plans and realistic prototype strategies. I often join projects at the stage where the idea is clear but the technical path is not. My role is to help teams answer critical questions such as: • What is the simplest prototype that validates the product idea • Which architecture decisions will scale to production • What technical risks should be addressed early • Which components and technologies are the right fit • What development roadmap makes the most sense Once the architecture is clear, I can support the development of functional prototypes including electronics, firmware, and mechanical integration. 🧠 TYPICAL STRATEGIC ENGAGEMENTS Prototype Architecture Review A deep technical review of a product concept or existing design to identify risks, validate architecture choices, and define the best technical direction. Clients typically leave with a clear architecture strategy and actionable recommendations. Prototype Roadmap Define the fastest and safest path from concept to working prototype. This includes system architecture, component selection strategy, and a realistic development roadmap. Technical Design Review Independent engineering feedback on an existing design before committing to development, manufacturing, or scaling. 🧭 HOW I USUALLY WORK Most projects start with a short architecture or prototype strategy engagement. This allows us to clarify: • system architecture • key components and technologies • technical risks • development roadmap Typical activities may include: • review of product concept, architecture and BOM • prototype architecture definition • identification of design and manufacturing risks • practical recommendations to simplify development • a clear next step roadmap This approach keeps projects efficient, predictable, and aligned with real world hardware constraints. 🔧 CORE EXPERTISE • hardware system architecture for embedded and IoT products • prototype strategy and rapid product validation • embedded systems and low power electronics • wireless systems including WiFi, BLE, Zigbee and LoRa • sensor systems and motor control architectures • system level integration across electronics, firmware and mechanics 🧪 PROTOTYPE DEVELOPMENT CAPABILITIES Once the architecture is defined, I can support the development of functional prototypes including: • electronic design and PCB development • embedded firmware development • sensor and wireless integration • mechanical prototyping with 3D modeling and printing My lab is equipped for rapid hardware development, allowing ideas to move quickly from concept to working hardware. 🚀 TYPICAL SITUATIONS WHERE I HELP • exploring a new hardware product idea • preparing the first functional prototype • evaluating or improving an existing architecture • reducing technical risk before major development investment • turning a proof of concept into a reliable prototype 🎯 FIT I work best with startups, innovators, and small product teams developing new hardware products. If you are exploring a product idea, preparing your first prototype, or trying to reduce technical risk before committing to development, I can help. If you are looking for open ended task execution or low level outsourcing, I may not be the right fit. 💬 LET’S TALK If you are working on a hardware product and want to move from idea to a realistic prototype strategy, I would be happy to discuss your project. Clear architecture decisions early in a project can save months of development and significant cost. Let’s build something real, testable, and engineered to succeed.

PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004

With more than 15 years of experience, I work with start-ups and SMEs to design, prototype and manufacture consumer products. I strive for close collaboration with clients and building personal relationships that last for years. I am the founder of Waterloo Technical Inc., a product development firm started in 2012. I specialize in industrial design; mechanical and electrical systems; firmware programming; and manufacturing. I work across these disciplines to transform great ideas into disruptive products that contribute to business growth for my clients.

A very dynamic, focused, and friendly individual with an excellent educational background and a track record of getting tasks done on time and with the highest standards. Able to handle high pressure, long hours, demanding deadlines, and significant responsibilities. I am well known for being very focused, self-motivated, organized, resourceful, and ambitious, concentrating my interest on positive morals and my organization's core values. I thrive on good work ethics, hard work, honesty, perseverance, and attention to detail. I am a fun-loving individual but I put much passion into my work and any task assigned to me. I believe I have much potential, and I always put my creative and analytical mind to good use, which I value highly. My interests include technical writing, healthcare applications, and medical research. Experience in DICOM, HIS/RIS systems, HL7, Teleradiology, PACS, Business Analysis and research.

I help companies and startups take physical products from concept to working, manufacturable prototypes. My work spans industrial design, mechanical engineering, and electrical system development, with a strong focus on building products that are practical to manufacture and scale. I typically work on products where industrial design, electronics, and mechanics must function as a single system, not as disconnected parts. Where I add the most value: Clients usually involve me when: • a product idea needs to be converted into a real prototype • mechanical and electrical designs are not aligned • early prototypes work but are difficult or expensive to manufacture • architecture decisions are unclear and causing redesign risk My approach focuses on defining the system correctly early, reducing rework, and preparing products for real-world constraints from day one. Core Services Industrial Design • Product concept development from sketches to 3D CAD • Enclosure and form design around electronics • Aesthetics aligned with usability and manufacturability Mechanical Engineering • Complete mechanical design and assemblies • DFMA, materials selection, and tolerance planning • Prototype and pre-production readiness Electrical & Embedded Systems • System architecture and electronics planning • Sensor integration and controller selection • Embedded and PLC-based system development End-to-End Product Development • Concept → prototype → pre-production • Design documentation and test planning • Support during manufacturing and supplier discussions Background I’ve worked on industrial and consumer devices involving electromechanical systems, automation, and embedded electronics. My experience also includes pre-production testing environments, test case development, and validation activities for complex hardware products. How I Work • Clear milestones and defined deliverables • Practical, documentation-driven communication • Engineering decisions grounded in manufacturability If you’re building a physical product and want it designed correctly before production, feel free to reach out with your current stage and goals.

I am a Certified Quality Auditor (CQA) with 7+ years of Quality & Regulatory Affairs work experience in the Medical Device, Pharmaceutical & Healthcare sectors. My main areas of focus are Regulatory Compliance and Standards, Quality Management Systems (QMS), Auditing, Document Review, Licensing and Post-Market Surveillance. I also possess expert knowledge in a handful of regulations including ISO 13485, ISO 9001, European MDR/MDD, FDA, Health Canada and MDSAP. Some of my other areas of expertise include technical writing of SOPs, quality forms, templates and work instructions as well as a proven track record of helping companies achieving Quality Management System compliance with ISO and other regulations. 📗 I'm always open to job offers, so please reach out to me and let me help you!