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Services

At AME Quality & Compliance Solutions, LLC. we offer a comprehensive range of services to help businesses navigate the complex world of quality and compliance assurance. 

Quality Assurance

At AME Quality & Compliance Solutions, LLC., we understand the importance of quality assurance. That’s why we offer a wide range of services to help our clients ensure the quality and safety of their products. Our core team of five Quality Assurance consultants have over 80 years of combined experience, making us well-equipped to handle all of your quality assurance needs. 

 

Our services include:

  • Quality system assessments

  • Quality management system development, implementation and certification, including ISO 13485

  • Identification of quality metrics

  • MDSAP 

  • Facility and Equipment Validation

  • Risk management and mitigation strategies

  • OSHA

  • CFR

    • 21 CFR 210

    • 21 CFR 211

    • 21 CFR 801

    • 21 CFR 803

    • 21 CFR 806

    • 21 CFR 807

    • 21 CFR 820

    • 21 CFR 210 211 (Pharmaceutical)

    • 32 CFR Part 1271 Biologics and Tissue

  • Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

  • Non-product Software Validation

 

Our team is dedicated to helping our clients achieve and maintain the highest standards of quality in their products and processes. Trust us to help you navigate the ever-changing landscape of quality assurance

Compliance Assurance

AME Quality & Compliance Solutions, LLC. offers a comprehensive approach to compliance assurance, ensuring that every aspect of your business is in compliance with the necessary regulations.

 

Our services include:

  • Quality System gap assessments

  • Current Good Manufacturing Practice

  • Corrective & Preventive Action, Investigations and Deviations

  • Auditing and inspection services

  • Supplier audits

  • Support for internal audits

  • Preparation and support for external audits, including front room/back room support and training

  • Employee training and education on compliance topics

  • Quality System management, development, implementation and remediation

  • Regulatory compliance consulting, including FDA and EU regulations

Remediation Support and Response

The team of industry professionals at AME Quality & Compliance Solutions, LLC. can help resolve regulatory challenges, including remediation and responses to notified body requests and findings. 

 

Our services include:

  • Current Good Manufacturing Practice

  • Quality System

  • Technical File

  • Design History File

  • Design Control Documentation

  • Notified body response including but not limited to FDA 483 response and FDA additional information request response

  • Warning letter response

  • Consent decree response

  • Remediation plan development and implementation

  • Facility improvements

Regulatory Affairs

AME Quality & Compliance Solutions, LLC. specializes in regulatory affairs for the medical device industry. Our team of experts has extensive experience working with the FDA, global regulatory bodies, and notified bodies worldwide. We understand the complexities of navigating the regulatory landscape and are dedicated to helping our clients bring their products to market efficiently and effectively. 

 

Our services include:

  • EU MDR

  • IVDR

  • Medical device establishment registration

  • Medical device listing

  • GUDID registration

 

Our team of industry experts can help guide you through the new product submission process, ensuring that all necessary documentation is in order and that your product meets the necessary regulatory requirements. We stay up-to-date on the latest regulations and guidelines to ensure that your product is compliant and market-ready.

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