CONSULTING
We offer a variety of QA consulting services to help you implement and maintain a Quality Management System.
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REGULATORY
We combine our knowledge and expertise to deliver results that successfully meet your requirements.
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AUDITS
We assist your organization meet your management systems requirements and ensure your supplier effectiveness.
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Services Include:
QMS IMPLEMENTATION
If your company is looking at implementing a Quality Management System (QMS) and becoming certified, we are here to guide you and make the process as smooth as possible.
We specialize in: ✓ ISO 13485:2016 – Medical Devices ✓ ISO 9001:2015 – General ✓ FDA GMP – Medical DevicesGAP ANALYSIS
We can evaluate your current performance in order to identify the differences between the current state of your business and its goals.
SUPPORT
We provide development support to management systems implemented, helping organizations to move forward towards their established goals.
free consultationRegulatory
Regulatory Services Include:
FDA REGULATIONS
✓ Facility Registration
✓ Product Listing ✓ Certificate to Foreign GovernmentPRODUCT REGISTRATION
✓ FDA – US
✓ CE Marking – Europe ✓ Latin America including: ∘ INVIMA – Colombia ∘ COFEPRIS – México free consultation
Audits
Audit Services Include:
INTERNAL AUDIT
Improve and optimize your Management System performing Internal Audits with experienced professionals in ISO/GMP audit processes.
SUPPLIER EVALUATION
Through audits and inspections, we can help in keeping your suppliers aligned according to your requirements. This is crucial in order to maintain or raise the quality of your product and, consequently, customer satisfaction.
CONFORMITY ASSESSMENT
Global competition means that organizations must comply with international standards to ensure quality of products and services. We can assist you to meet the established, accepted and internationally recognized conformity assessment requirements.
free consultation
AG Consulting Group
We offer a customized service to our clients with the mission of satisfying their needs, providing them solutions related to process management, quality assurance and compliance with regulatory requirements.
We have more than 12 years of experience in the area of implementation of Quality Management Systems for medical equipment manufacturers. Achievments in ISO 13485 and ISO 9001 Certifications, US FDA GMP implementation and European Certification (CE Marking) We deliver real value, successful solutions, and world-class service.
Confidenciality
Our commitment to clients is to jealously safeguard the confidentiality of their property rights and do not disclose information related to products or technological development to any third parties.
Customer Service
We maintain the commitment to serve our clients in a timely manner with professionalism, kindness, courtesy, and ethics. The focus is on solving the identified need, using our experience and technical knowledge. We ensure clear, effective and continuous communication.
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Consult any of our services for free