Expert Services

Third-Party Inspections for MDs & IVDS

Ensure Compliance, Quality & Reliability with Alpine Quality Consultants

At Alpine Quality Consultants, we provide independent third-party inspection services to help medical device (MD) and in vitro diagnostic (IVD) manufacturers ensure product quality, safety, and regulatory compliance. Our expert inspectors conduct thorough evaluations at various stages of production, from raw material inspection to final product release, ensuring adherence to ISO 13485, MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, and MDSAP standards.

Why Choose Third-Party Inspections?

  • Unbiased Quality Assessment – Independent verification of product compliance
  • Regulatory Compliance – Ensure adherence to ISO 13485, MDR, IVDR, FDA, and MDSAP
  • Reduce Defects & Rework – Identify issues early to prevent costly recalls
  • Supplier Quality Control – Ensure raw materials & components meet specifications
  • Improve Customer Confidence – Guarantee high-quality, regulatory-compliant products

Our Third-Party Inspection Services

Incoming Material & Component Inspection

  • Verify raw materials, components, and subassemblies before production
  • Ensure compliance with technical specifications & regulatory requirements
  • Identify non-conforming materials before they affect production

In-Process Inspection & Monitoring

  • Conduct real-time production line inspections to detect defects early
  • Verify adherence to manufacturing procedures & quality standards
  • Ensure compliance with Good Manufacturing Practices (GMP)

Pre-Shipment & Final Product Inspection

  • Perform final product verification before shipment
  • Ensure product labeling, packaging, and documentation meet regulatory requirements
  • Prevent defective products from reaching the market

Packaging & Labeling Compliance Inspection

  • Confirm that labeling meets MDR, IVDR, FDA, and other market-specific regulations
  • Verify that packaging protects the product & maintains sterility (if applicable)
  • Prevent mislabeling, a key cause of regulatory non-compliance

Supplier & Manufacturing Facility Inspections

  • Assess supplier quality management systems (QMS)
  • Conduct audits to verify ISO 13485 & regulatory compliance
  • Ensure risk-based supplier management strategies

Risk-Based Inspections & Process Validation

  • Conduct risk assessments in compliance with ISO 14971:2019
  • Validate critical manufacturing processes to maintain consistent product quality
  • Ensure that non-conformities are detected & addressed proactively
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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