Regulatory & Quality Consulting
Access the
Canadian market
Your device's path into the Canadian market hinges on effective regulatory alignment rooted in strategic decisions made long before your license application is filed. Getting this right the first time is what keeps your timeline and budget on track.
Over two decades of direct MedTech regulatory experience.
We help you build the compliance strategy your product needs, from initial device classification through post-market compliance, calibrated to Health Canada’s specific requirements. Whether you are launching your first device, scaling into a higher device class, or preparing for an acquisition, we shape our approach around where your business is, so you can stay ahead of evolving standards and regulations instead of reacting to them.
Regulations we Specialize In
Whatever stage your device is at, from proof-of-concept to full commercial scale, we provide Canadian regulatory advising built around your technology and what is required to bring it to market.
Medical Device Licence
We manage the full submission process for Medical Device Establishment Licensing, Medical Device Licensing across Class II through IV, and Investigational Testing Authorizations for clinical investigations, from initial risk classification through approval.
Quality Management System (MDSAP)
We build and audit quality management systems compliant with ISO 13485 and certified through MDSAP, the audit program Health Canada requires for Class II through IV device licensing, so your QMS holds up under a single, multi-jurisdiction audit.
Post-Launch
Compliance
We support Mandatory Problem Reporting, recall management, and Annual Licence Renewals, so your product stays in good standing with Health Canada long after your licence is granted.
NO SINGLE REGULATORY STRATEGY HOLDS STEADY AS YOUR DEVICE, YOUR PRODUCTION VOLUME, AND YOUR TEAM CHANGE.
We help you recognize when your device class, intended use, or growth stage calls for a different approach, before those changes catch you off guard.
Hasnaa Fatehi, PhD
OUR CHIEF EXECUTIVE OFFICER
Hasnaa has two decades of MedTech experience including clients such as Procter & Gamble, Stryker and LivaNova.
Her academic background, a BSc in Mechanical Engineering, an MSc in Biomedical Engineering with a focus on Ultrasound imaging, and a PhD in Systems Biology, gives her a technical fluency in device design controls and risk analysis.
- ISO 13485 Lead Auditor, certified
- RAC (Devices), certified
- RAPS (Regulatory Affairs Professionals Society), member, Former Chapter Chair, RAPS Western Canada
- TOPRA (The Organisation for Professionals in Regulatory Affairs), member, former MedTech Committee Chair
- Founder, Western MedTech
- Member, MedTech Canada
Hugo Vite Caritino, Country Manager, Flexicare Global“We hired Qaralogic for support with regulatory remediation support following an acquisition by Flexicare. Hasnaa has an excellent understanding of Canadian Regulations, is a great communicator who enjoys educating her clients to ensure they can do the work on their own. She made the submission processes very transparent and assisted us until successful completion.”
