Regulatory & Quality Consulting
Access the US market
Your device's path into the US 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 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.
We Specialize In:
Whatever stage your device is at, from proof-of-concept to full commercial scale, we provide US regulatory advising built around the technology and requirements to bring it to market.
Market Clearance
We manage the full submission process across Q-Sub, 510(k) and De Novo pathways, including meetings with FDA, technical documentation, and eSTAR preparation, from risk classification through clearance.
Quality Management System Regulation (QMSR)
We build and audit quality management systems aligned to the FDA’s Quality Management System Regulation, covering design controls, CAPA, document control, and internal audits, so your QMS holds up under inspection.
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, RAC (Devices)
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
Nelson Pang, President, RAZ Design“We selected Qaralogic out of a list of several consultants to help with a US FDA project. The team tackled our project with expertise, dedication and timeliness.”
