Canadian Quality & Regulatory Consulting

Compliance That Moves Your Product Forward.

Health Canada audits, ISO 13485 certification, FSMA compliance — we've helped Canadian medical device and food companies navigate every major regulatory hurdle. Let's tackle yours.

  • Lead Auditor ISO 13485
  • MDSA — Medical Device Single Audit Program
Standards:ISO 13485Health Canada MDRFSMA / HACCPBRCSQFFSSC 22000MDSA

Sound Familiar?

We solve the compliance challenges that slow Canadian companies down.

Preparing for a Health Canada inspection?

We conduct thorough gap analyses and readiness assessments so there are no surprises on audit day.

How we help

Struggling to achieve ISO 13485 certification?

We guide your QMS development from documentation through certification — and beyond.

How we help

Need a food safety plan for FSMA or HACCP compliance?

We build regulatory strategies tailored to your product, facility, and target market.

How we help

Our Services

End-to-end regulatory support.

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Strategic Planning

We develop tailored regulatory strategies for medical devices and food safety, guiding your organization from concept to market. Our team assists with certifications (BRC, SQF, FSSC 22000) and submission to health authorities.

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Internal Audits & QMS

Rigorous internal audits and Quality Management System support ensure your organization meets every applicable standard before a Health Canada inspection. We handle gap analysis and comprehensive documentation.

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Operational Efficiency

We collaborate with your cross-functional teams to embed quality into everyday operations, lead regulatory projects, and build internal capacity through targeted training programs.

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Our Process

A clear path from uncertainty to compliance.

01

Assess

We start with a thorough review of your current regulatory position, identifying gaps and risks before they become problems.

02

Strategize

We build a clear, prioritized compliance roadmap aligned to your product timeline, certifications, and target markets.

03

Execute

We work alongside your team — handling documentation, audits, submissions, and training — so nothing falls through the cracks.

04

Sustain

Regulations evolve. We help you build the internal capacity to stay compliant long after our engagement ends.

Founder

Rama Pashai

Hami Health Services

  • Lead Auditor ISO 13485
  • MDSA — Medical Device Single Audit Program
Meet Rama

About Hami Health

Expertise built on the front lines of Canadian compliance.

Hami Health Services was founded on a straightforward conviction: Canadian health companies deserve a regulatory partner as invested in their success as they are.

Founder Rama Pashai brings the precision of a certified lead auditor and the approachability of a trusted advisor — combining deep technical expertise in ISO 13485, Health Canada MDR, and food safety frameworks with a genuine commitment to client outcomes.

Ready to bring your products to market safely?

Let's talk through your compliance goals — no obligation, no jargon.

Schedule a Free Assessment