MS Certification Services

21 CFR 820 QSR

21 CFR 820 QSR Consultancy Services

Achieve Compliance with FDA Quality System Regulations (QSR)

At Alpine Quality Consultants, we specialize in helping Medical Device and In Vitro Diagnostics (IVD) manufacturers navigate the complex requirements of 21 CFR Part 820—the FDA Quality System Regulation (QSR). Our expert consultants provide tailored guidance to ensure your Quality Management System (QMS) meets FDA expectations, reducing compliance risks and facilitating smooth market entry.

Why Compliance with 21 CFR 820 Matters

The 21 CFR Part 820 QSR establishes the quality system requirements that medical device manufacturers must follow to ensure product safety, effectiveness, and regulatory compliance in the United States. Non-compliance can lead to:

FDA Warning Letters & 483 Observations

Product Recalls & Market Restrictions

Legal & Financial Consequences

Delays in Product Approvals & Market Access

Our 21 CFR 820 Compliance Services

We offer comprehensive consulting services to help you establish, maintain, and improve your FDA-compliant Quality System, including:

QMS Development & Implementation

  • Establish or upgrade your Quality Management System (QMS) to align with FDA QSR requirements
  • Develop and document Standard Operating Procedures (SOPs)
  • Integrate ISO 13485 with 21 CFR 820 for global compliance

Gap Analysis & Compliance Audits

  • Identify non-compliance risks through QMS audits
  • Conduct FDA mock inspections to prepare your organization for real FDA audits
  • Provide detailed reports and corrective action plans

Remediation & CAPA Support

  • Address FDA 483 observations, Warning Letters, and compliance gaps
  • Implement effective Corrective and Preventive Action (CAPA) plans
  • Ensure continuous QMS improvement and compliance sustainability

Supplier & Manufacturing Compliance

  • Audit and qualify suppliers & contract manufacturers for FDA compliance
  • Establish risk-based supplier management programs
  • Ensure process validation & production controls meet QSR standards

Training & Regulatory Support

  • Train teams on 21 CFR 820 requirements & FDA expectations
  • Provide ongoing regulatory updates & best practices
  • Assist with FDA communications & pre-audit preparations
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

Links

Services

Contact

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

© Alpine Quality Consultants 2025 | All Rights Reserved

TOP