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Empowering
Medical
Innovations

Empowering
Medical Innovations

Expert Regulatory &

Quality Solutions Since 2021

Expert Regulatory & Quality Solutions Since 2021

Meet the Founder

With over 30 years at the helm of quality and regulatory affairs for Medtronic, US Surgical, Johnson & Johnson, Fujifilm and more, Joseph Azary founded Aztech Regulatory & Quality LLC to bring uncompromising expertise, and genuine integrity, to every medical device project.

Joseph Azary, Regulatory Expert

I turn complex regulations into clear, actionable pathways,

so you can focus on innovation.

Education: B.Sc. Biological Sciences (UConn); MBA (Public Health, Sacred Heart); Regulatory Affairs graduate courses (Northeastern).
Certifications: ASQ Certified Quality Auditor (CQA); Biomedical Auditor (CBA); RAC since 1996.
Specialized Training: EU MDR, MDSAP, Process Validation, ISO 13485, ISO 14971, FDA QSR, Software Validation, FDA QMSR and Auditing.
Leadership Roles: VP of Quality & Regulatory at Z‑Medica (9+ yrs); founder of Azary Technologies (180+ clients; acquired 2008). Director of Quality/Regulatory at Sekisui Diagnostics, Manager of Quality/Regulatory Consulting Group at Orchid Orthopedic Solutions.

OnLine & OnSite Training

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Get quick, actionable insights on specific regulatory topics. Perfect for professionals who need clarity on a single issue fast. Fast, focused, and effective in just one session

One-Time Lessons

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Deep-dive into core regulatory systems like ISO 13485, FDA 510(k), and MDSAP European Union MDR and FDA QMSR. Multi-module courses.

Full Course Classes

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Personalized guidance. Book a direct session with Joseph Azary and get expert feedback on your compliance strategy, submission, or audit readiness.

1-on-1 Advisory

ABOUT OUR COMPANY

We Provide Professional Regulatory Solutions

At Aztech Regulatory & Quality, we blend over 30 years of industry experience with a results-oriented approach. Our consulting solutions ensure compliance, efficiency, and integrity, helping you bring medical innovations to market faster

180+

Global Clients

30+

Years of Experience

9 YRS

VP of Quality

OUR RESOURCES

Build Compliant Businesses That Last

OUR SERVICES

We Offer a Range of Services for Medical Device Companies

Whether you’re a startup, a virtual operation, or an established business, Aztech Regulatory & Quality provides flexible and tailored solutions. Let us partner with you in navigating global regulations, ensuring compliance every step of the way.

Regulatory Strategy

Develop customized regulatory pathways to launch your product quickly and safely.

Quality System Development

Implement or improve QMS to align with ISO 13485, FDA QSR, EU MDR, FDA QMSR, and MDSAP requirements.

Regulatory Submissions

Prepare and file 510(k)s, CE Mark, Canadian Licensing, & more.

Training & Auditing

Gain practical knowledge via in-depth training sessions; plus auditing for suppliers, internal processes, or gap assessments.

OUR CLIENTS

Trusted By Startups and Established Firms Worldwide

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