Aztech Regulatory & Quality is a full service consulting business for the medical device industry. We believe in keeping things simple, efficient, results oriented, practical, reasonable and with full integrity.
Joseph Azary has been in the medical device industry in various quality and regulatory roles for over 30 years. Joseph has a bachelor's degree in Biological Sciences from University of Connecticut, Masters Degree (MBA) with a concentration in Public Health from Sacred Heart University and has completed graduate courses in Regulatory Affairs at Northeastern University.
Joseph has worked for United States Surgical (now part of Medtronic), Johnson & Johnson, Sekisui Diagnostics and Fujifilm Medical.
Joseph owned Azary Technologies where he worked with over 180 medical device companies globally on a variety of regulatory and quality projects. He sold Azary Technologies to Orchid Orthopedic Solutions in 2008.
Most recently (for over 9 years) Joseph was the Vice President of Quality & Regulatory at Z-Medica, LLC.
Joseph is an ASQ Certified Quality Auditor (CQA) and ASQ Certified Biomedical Auditor (CBA). He was Regulatory Affairs Certified (RAC) in 1996. He has specialized training in EU Medical Device Regulations, MDSAP requirements, Process Validation, Risk Management ISO 14971, ISO 13485, FDA QSR and software validation.
Your Strategic Partner
I have the knowledge and experience to meet and exceed your expectations, and offer a variety of services customized to fit your specific needs. Learn more about the improvements I can help you achieve, and contact me today.
The Path to Success
My services are customized to meet the specific needs of each client. I work collaboratively throughout the entire process and guarantee measurable results. This includes development of regulatory strategy. Contact me to find out how I can help today.
QUALITY SYSTEM DEVELOPMENT
A Comprehensive Approach
We will assist you with the development or improvement to your quality management system to best comply with ISO 13845, FDA QSR, EU MDR, and MDSAP requirements. We customize the approach to fit your business. Our specialty is small to medium sized businesses including virtual and start-up companies.
We can assist you with the preparation and filing of regulatory submissions including FDA 510(k)s, CE Certification for European Union, Canadian Licensing and other international registrations.
TRAINING AND AUDITING
The Path to Success
We can provide training courses on a variety of quality & regulatory topics. We also provide auditing services including supplier audits, internal audits, due diligence audits, and gap assessments.