#1
12th December 2015, 06:13 PM
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QA Consulting Companies
I want to know the services offered by the QA Consulting Company so can you please tell me?
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#2
13th December 2015, 12:04 PM
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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 |