Strategic Quality Solutions

Crafting Excellence in Quality Assurance Strategies

Explore our Quality System Services, meticulously crafted to ensure alignment with industry standards and regulatory requirements. Benefit from our extensive expertise in developing and implementing robust quality systems tailored to your organization’s unique specifications.

Choose MAE Group as your partner in quality system management for expert guidance and comprehensive support. With our focus on FDA and ISO compliance, we ensure your business thrives while maintaining regulatory standards. From system creation to verification and validation, trust MAE Group to drive excellence and success in quality assurance.

Jay Shah
Biomedical Engineer
Email: [email protected]
Phone: +1-603-505-7664

Connect with Jay
Quality Management System for Medical Devices

Our Expertise​

We take pride in being the go-to option for quality system management, distinguishing ourselves from competitors through various key aspects.

Quality Document Guidance

Expert Guidance

Trust MAE Group’s experts for FDA 483 findings, warning letters, or adverse findings. We provide assistance and support for the remediation process, ensuring your business growth remains on track.

Quality Assurance and Design Review

Complete Competence

Rely on our extensive knowledge in quality assurance review. We excel in auditing vendors, their quality systems, products, and design and production environments, maintaining your business’s good standing.

best quality management system support

Full-Cycle Support

MAE Group supports you from idea to post-market surveillance. With a focus on verification, validation, and expert guidance, we ensure the quality management system is a backbone for quality success.

Key Insights

Numbers Speak

26%

An increase in profitability is observed by companies effectively implementing quality management practices.

$13750 Mn

is the projected market size of the global Quality Management System (QMS) Software, up from USD 7815.38 Million in 2022.

2.5 Mn

deaths could be prevented by implementing high-quality health systems, including 900,000 deaths from tuberculosis and 1 million newborn deaths.

Key Features

Discover the top features that make our product unique and powerful.

System Creation

We craft phased quality systems tailored to your company’s life cycle. MAE Group provides comprehensive quality system creation and staff training for seamless integration.

Assurance Activities

Our team manages quality assurance through design, post-market surveillance, and vendor auditing. Specializing in FDA and ISO compliance, we ensure excellence throughout the process.

Verification & Validation

Navigate product and process verification with MAE Group. Our Quality Team specializes in FDA and ISO-compliant verification and validation for both medical devices and pharmaceuticals.

Take Action Now

Navigating Quality Systems with Precision and Compliance

Navigate a refined quality system journey with us. We craft tailored systems, manage assurance seamlessly, and specialize in FDA and ISO compliance. Trust us for expert guidance in FDA 483 findings, ensuring a robust quality system backbone for success. Your partner in shaping a future of quality system excellence.

Latest Case Studies

Explore breakthroughs and success stories in our compelling success stories.

Address

250 Commercial Street, Suite 3007, Manchester, NH 03101

Call Us

+1 603-505-7664

Email Us

[email protected]

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