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13th December 2015, 12:04 PM
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Join Date: Apr 2013
Re: QA Consulting Companies

QA Consulting Company is to provide medical device manufacturers with exceptional consulting services that fulfill our clients’ internal goals while complying with regulations, and industry practice.

The medical device landscape is fast-paced and constantly evolving.

Services-


Quality Systems

Their extensive experience in quality systems includes the following:

Quality Management System Development & Implementation

Quality System Training

Design Control

Design Verification and Validation

Inspection Services

Virtual Document Control

Post Production Services:

Nonconforming Material Reports
Complaint Handling
Medical Device Reporting (MDR)
Corrective Actions and Preventive Actions (CAPA)
Management Review
Health Hazard Evaluations (HHE)
483 and Warning Letter Responses

Risk Management

Audits-

Audits are vital and unavoidable in the medical device industry.

They provide the required independent and objective party for quality system audits, including:

Internal and Supplier Audits (US FDA 21 CFR Part 820; 21 CFR Part 11; ISO 13485; ISO 17025; etc)
Sterilization Systems (ISO 11135; ISO 11137; ISO 17655; ISO 14160; etc)
Mock FDA Audits
Good Laboratory Practices (GLP), including 21 CFR Part 58
Compliance Gap Assessment

Regulatory Affairs-

They prepare regulatory strategies with submissions and registrations for:

513(g)
510(k)
Premarket approval (PMA)
Investigational Device Exemption (IDE)
Technical Files and Design Dossiers

Microbiology-

Their microbiology services include:

Biocompatibility Assessments
Sterilization Efficacy and Validation Studies for ethylene oxide (EO), gamma, e-beam, and moist heat (steam) processes
Cleaning and Disinfectant Efficacy and Validation Studies for Reusable Devices
Cleanroom Qualification and Monitoring

Contact details-

QA Consulting, Inc.

7500 Rialto Blvd.
Bldg. 1, Ste. 225
Austin, Tx 78735
Tel: 512.328.9404
Fax: 512.532.9434


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