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Thomas is the Founder and General Manager of PTL Solutions Inc., a Montreal-based consulting firm that helps medical device and combination product companies accelerate development and achieve regulatory and quality compliance efficiently. With 25 years in product development, more than 20 of them in the medical device industry, Thomas has led projects spanning regulatory strategy, quality management, product development, and market access under FDA, Health Canada, and EU frameworks. PTL Solutions was created with a clear mission: to deliver exceptional value by engaging only highly experienced consultants, each bringing 15 to 25 years of hands-on expertise. The firm supports startups and established manufacturers alike with hardware and software development, clinical testing, and usability engineering. Under Thomas's leadership, and with a highly skilled and experienced cross-functional team, PTL Solutions streamlines each client's journey from concept to commercialization.

Anthony has more than 12 years of regulatory affairs and quality experience across medical devices and diagnostics. At MY01 he led regulatory affairs and quality management as Management Representative, building the company's quality system from the ground up and securing a traditional 510(k), an EU Technical File, and a Health Canada Class II medical device licence. Earlier roles at Roche Diabetes Care, Roche Diagnostics, and Jubilant DraxImage gave him hands-on experience with recalls, mandatory problem reporting, licence amendments, promotional material review, and Health Canada audits. He is a certified ISO 13485 lead auditor and has conducted internal and supplier audits and set up post-market surveillance programs. He also serves as Director of Quality Assurance and Regulatory Affairs at Endocision. At PTL, Anthony takes clients from regulatory strategy through to a cleared submission, and builds quality systems sized to the stage of the company.

Sam has more than 30 years of regulatory and quality experience across medical devices, pharmaceuticals, and biotech. He led quality and regulatory affairs at Conavi Medical, Vital Connect, and Sonitus Medical, where he authored 510(k) submissions, obtained CE marks and Health Canada licences, and achieved ISO 13485 and MDSAP certification. As Senior Director of Software RA/QA at Freenome, he worked with FDA and industry leaders on change-control templates for AI/ML-enabled software. His work spans SaMD, digital health, IVDs, surgical robotics, and combination products, with submissions ranging from 513(g) requests through De Novo and PMA, and he has supported MDD to MDR transitions for several manufacturers. Sam also serves as an authorized U.S. Agent for international manufacturers. At PTL, he gives clients an experienced voice with FDA, particularly on software and AI.

Joelle has more than 20 years of experience in regulatory compliance, quality systems, and product development for medical devices. At Zimmer Biomet she served as Product Owner, Scrum Master, and Design Quality Engineer for robotic and navigation systems, leading verification and validation, design control remediation, and MDR transition activities for Class II and Class III devices. Her work has supported 510(k) and Technical File submissions and human factors validation with clinical teams, in close collaboration with regulatory, R&D, and quality stakeholders. She brings deep knowledge of FDA and EU regulations, ISO 14971 risk management, and Agile product development, and works with both start-ups and large manufacturers. At PTL, Joelle turns regulatory requirements into design and testing plans that engineering teams can execute.

Abdel has more than a decade of experience in clinical strategy and medical affairs, supporting medtech companies across the development lifecycle. He has planned and run clinical trials under GCP and ISO 14155, built and scaled KOL engagement strategies, managed medical advisory boards, and overseen the publication of clinical data through abstracts and peer-reviewed articles. At MY01 he directed a major expansion of the medical affairs program, tripling KOL engagement and peer-to-peer activity while managing a team and launching professional education initiatives. Before that, at NXTSENS, he secured more than $5.5M in non-dilutive funding and built the company's early clinical data strategy. His background is in virology and immunology research. At PTL, Abdel helps clients design trials, engage clinical stakeholders, plan medical education, and fund their clinical programs.

Natalie is a practicing clinician, researcher, and educator in hospital internal medicine at Mayo Clinic Florida, and the founder of a clinical strategy consultancy. She brings a frontline view of how care is delivered, along with an understanding of the operational and economic pressures that shape purchasing and adoption decisions. Her research interests include inpatient integration of wearable medical technology, electronic health record optimization, and disaster preparedness, and she serves as a subject matter expert on internal committees focused on practice and EHR optimization. At PTL, Natalie helps clients define the unmet need, map clinical workflows, identify adoption drivers for each stakeholder, and anticipate implementation barriers before deployment. She also coaches founders on building a clinical narrative that resonates with physicians, hospital leaders, and investors.

Loren has more than 10 years of experience in human factors engineering for medical and pharmaceutical products, built at Baxter, Emergo by UL, and Kaleidoscope Innovation. She has worked with Fortune 500 companies, start-ups, and manufacturers of every size, planning and running human factors programs end to end. Her work covers human factors strategy, usability studies, use-related risk analyses, protocols, and reports that have supported successful submissions to FDA and international regulators. Products she has supported that are now on the market include a NIPRO hemodialysis machine, Tandem's t:connect mobile app for its insulin pump, and Skyrizi. She holds bachelor's degrees in bioengineering and biochemistry from the University of Illinois at Chicago. At PTL, Loren makes sure a client's device is demonstrably safe and usable before the regulator asks.

Philippe has more than 20 years of experience in embedded software development, including 15 in medical devices. At Neurostream Technologies he was principal firmware engineer and later technical lead for an implantable neurostimulator, leading a team of seven engineers through development and verification of Class C software under IEC 62304. As an independent expert he has since supported 510(k) and CE mark submissions for diagnostic imaging, cardiac monitoring, radiotherapy, oxygen therapy, and ophthalmic devices. His work covers system and software risk analysis, cybersecurity risk files, verification and validation planning, traceability, source code review, and validation of SOUP and quality system tools such as eQMS and electronic signature software. He holds a bachelor's degree in software engineering from Université de Sherbrooke. At PTL, Philippe makes sure a client's software and its documentation hold up under regulatory review.

Chrouk has more than 9 years of experience in medical device software, from embedded development to department leadership. At MY01 she progressed from embedded developer to Senior Manager of Software Engineering, leading embedded, mobile, and back-end teams and managing the full lifecycle of connected products. She prepared software documentation for 510(k) submissions that led to FDA clearance, established software lifecycle processes under IEC 62304, and built the company's cybersecurity procedures along with its SOC 2 and HIPAA programs. She also secured $1.4M in non-dilutive funding for her team's projects. She also serves as Staff Software Engineer at CooperSurgical, where she leads software development for a Class II fertility incubation and imaging platform. Chrouk holds a Bachelor of Engineering in Electrical Engineering from McGill University. At PTL, she has served as interim software manager on a Class III device and reviews software and cybersecurity design for connected products.

Bryan is a software, firmware, and systems engineer with more than 15 years of experience developing complex, cross-disciplinary products, including nearly six years building medical devices at StarFish Medical in a regulated design environment. His technical range covers embedded C on Linux and a variety of microcontrollers, FPGA design in VHDL and Verilog on Xilinx and Altera platforms, and application development in C++, C#, Qt, and Go. He is comfortable at the system level, taking a concept from early prototype through pre-production, and in the detail of drivers, communication protocols, and hardware and software integration. Bryan has also managed engineering teams, led multidisciplinary projects spanning industrial design, mechanical, electrical, and software work, and written and executed verification tests. At PTL, he delivers software and firmware developed with the discipline and traceability a regulated product requires.

Liisa has more than 25 years of quality, engineering, and operations leadership in diagnostics, medical devices, and regulated laboratories. She spent more than two decades at Abbott, starting in the development and manufacturing of biosensors for the i-STAT point-of-care platform and rising to Director of Quality and Compliance for Abbott's US toxicology laboratories, where she led quality across four regulated facilities serving government, workplace, clinical, and forensic testing. Along the way she owned a business unit quality system spanning 17 sites worldwide and served as quality system integration lead for Abbott Diagnostics mergers and acquisitions. She has built, run, and been audited against the systems she now designs. At PTL, Liisa leads work with diagnostics and laboratory clients on quality system design and remediation, GLP and GMP compliance, and preparing for regulatory scrutiny as they scale.

Tamara has more than 25 years of experience in the in vitro diagnostic and medical device industries, with specialized expertise in point-of-care, CLIA-waived, and whole blood tests. She was a core member of the team that developed and commercialized the first i-STAT immunoassay, cardiac troponin. At Abbott Point of Care she worked with the US Department of Defense to create the pre-market clinical and regulatory strategy for the i-STAT Traumatic Brain Injury test, which received breakthrough device designation and has since been cleared by FDA. As Director of Regulatory and Quality at SQI Diagnostics, she achieved MDSAP certification and product licensing with Health Canada. Trained as a chemical engineer, her experience spans assay development, manufacturing, clinical study design, statistics, and quality systems. At PTL, Tamara shapes clinical and regulatory strategy for novel diagnostics, including FDA pre-submission meetings, design controls, and risk management.

Rana is a professional engineer with more than 25 years of experience across diagnostics, hospital technology, and digital health. She spent nearly 15 years at i-STAT and Abbott Point of Care, starting on the core engineering team and rising to Head of Quality Operations, where she built the validation engineering function, established foundational quality systems, and represented the company in FDA audits. She went on to direct medical device engineering and operations at The Ottawa Hospital, lead healthcare and life sciences engagements at IBM, build the enterprise project management office at Canadian Blood Services, and serve as Chief Operating Officer of a digital health start-up. She is now Vice President and Practice Leader at Stratford, a management consulting firm, and brings both the manufacturer's and the hospital's perspective. At PTL, Rana helps clients build quality operations that scale and products that hospitals can adopt.