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.
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
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
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
180+
Global Clients
30+
Years of Experience
9 YRS
VP of Quality
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