Aztech Regulatory & Quality LLC

Name: Aztech Regulatory & Quality LLC
Address: 543 Long Hill Avenue, Shelton, CT, 06484, US
Telephone: +12032426670

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Aztech Regulatory & Quality LLC

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Consulting firm specializing in medical device regulatory & quality services including FDA compliance, ISO 13485, 510k submissions, quality system development, auditing and training.

06/12/2022

We have some spots open for an upcoming Design Control training course that I will be teaching the week of June 20 - 24. This a remote course taught over 5 days (1/2 day sessions). Please see the information below.

Design Control Training for Medical Devices: Requirements and Best Practices

In this training course, learn strategies and best practices for managing your medical device design and development control process.

04/06/2022

Aztech Regulatory & Quality LLC offers US Agent services for non-US based medical device companies. Services include:
- Designated US Agent
- FDA Establishment Registration and Device Listing
- eMDR Reporting
- Recall Coordination
- Label Review
- Complaint Coordination (for use originated complaints)

Contact us at [email protected] to learn more.

08/06/2021

Coming soon. November 1, 2021 Aztech Regulatory and Quality will go live. Guess who's back? with Joseph Michael

Address

543 Long Hill Avenue
Shelton, CT
06484

Telephone

+12032426670

Website

http://www.aztechregulatory.com/

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