Regulatory & Quality Consulting
Access the
global market
Your device's path into the global market hinges on effective regulatory alignment rooted in strategic decisions made long before submission. 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 risk classification through post-market compliance. Whether you are launching, scaling, remediating, 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 global regulatory advisory built around the technology and requirements to bring it to market.
Global Market Clearance
We manage the full submission process from risk classification through approval, covering ANVISA registration in Brazil, TGA conformity assessment and ARTG inclusion in Australia, and PMDA Shonin and Todokede pathways in Japan.
Global Quality Management Systems
We build and audit quality management systems aligned to ISO 13485, meeting ANVISA’s BGMP requirements in Brazil, TGA’s QMS conformity assessment in Australia, and the QMS Ordinance under Japan’s PMDA, covering design controls, CAPA, document control, and internal audits, so your QMS holds up under inspection or an MDSAP audit.
Post-Launch
Compliance
We can guide your UDI implementation, complaint handling, Medical Device Reporting, and post-market surveillance, so your product stays in good standing long after clearance.
NO SINGLE REGULATORY STRATEGY HOLDS STEADY AS YOUR DEVICE, YOUR PRODUCTION VOLUME, AND YOUR TEAM CHANGE.
We help you recognize when your risk classification, 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 includes a BSc in Mechanical Engineering, an MSc in Biomedical Engineering with a focus on Ultrasound imaging, and a PhD in Systems Biology – giving her a technical fluency in device design and risk which can be critical for complex and detailed compliance systems.
- 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
Scott Crawley, CEO, Compass HealthAI Applications Inc.“Qaralogic’s expertise in stewarding our organization through ISO 13485 MDSAP audit(s) in record time without compromising quality, and smoothly implementing our eQMS was invaluable. Their strategic problem-solving skills significantly advanced our compliance and accelerated market readiness.”
