The Qaralogic Team
Our partners represent a group of highly specialized MedTech practitioners, each with decades of direct experience in a single discipline, from regulatory strategy and quality systems to clinical operations, human factors, reimbursement, and commercialization.
85+ years
of combined Medtech expertise
Bringing medical devices from bench to patients across our consulting team.
900M+ people
reached in top six jurisdictions
Average client clears Canada, US, EU or ASEAN, UK, Australia and the Middle East through a single engagement.
1,680+ SOPs & QMS
documents authored
Across ISO 13485, MDSAP and EU-MDR quality systems.
35% faster
time to market on average
Through lean QMS design and right-first-time submissions.
John Fengler, P.Eng, Senior Director, R&D, Technology Development, Stryker“I know the Qaralogic team to be professionals of the highest integrity and very conscientious and knowledgeable.”
Our partners represent a group of highly specialized MedTech practitioners
Each has decades of direct experience in a single discipline, from regulatory strategy and quality systems to clinical operations, human factors, reimbursement, and commercialization.
Hasnaa Fatehi, PhD, RAC (Devices)
REGULATORY & QUALITY ASSURANCE
- Hasnaa is a certified MedTech regulatory affairs and quality assurance professional with over 20 years in MedTech and experience across Asia, Europe, and North America.
- She served as Chair of the TOPRA MedTech Committee from January 2021 to May 2023 and as RAPS Western Canada Chapter Leader from January 2023 to December 2024.
- In January 2024 she founded Western MedTech, an early-stage focused industry group dedicated to advocacy, collaboration, and the adoption of Canadian medical technologies in Canada.
Edward Dougherty
US REIMBURSEMENT
- For more than 30 years, Ed has worked directly with founders, executives, board members, and investors to help them understand the many distinct healthcare markets that make up the United States.
- His expertise spans SaMD, digital health, diagnostics, IVDs, and medical devices across a wide range of practice areas.
- He speaks regularly on these topics internationally and advises companies in Canada, the UK, across the EU and the Nordics, Israel, and Korea.
Chris Franckhauser
COMMERCIALIZATION & US MARKET ENTRY
- Chris is a commercialization strategist and healthcare executive with more than 20 years of experience helping founders and leadership teams turn innovative technologies into successful businesses.
- Drawing on leadership roles across Fortune 15 companies and high-growth startups, he specializes in commercialization strategy, go-to-market execution, and U.S. market entry for MedTech, biotech, and digital health companies.
Dan Came
MEDICAL DEVICE DEVELOPMENT & HUMAN FACTORS
- With over 15 years in MedTech, Dan excels at breaking down regulatory requirements into plain terms and providing practical tools and methods to meet them.
- Focused on usability and safety, he helps teams navigate the complexities of harmonized standards through a lean, expert-driven approach to product development.
Loes Pelgrim
EU CLINICAL OPERATIONS & REGULATIONS
- Loes is a seasoned, proactive clinical operations expert.
- She is results-driven with a focus on execution, monitoring, and project management, and brings a genuine passion for training and driving regulatory compliance under ISO 14155, ICH-GCP, and EU-MDR.
