Expert Services

OURSOURCE QA

OURSOURCE QA

At AQC, we provide comprehensive outsourced Quality Assurance (QA) solutions for medical device and in vitro diagnostic (IVD) manufacturers. Our expert QA outsourcing services ensure regulatory compliance, risk management, and continuous quality improvement, helping businesses meet the requirements of ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA regulations.

Why Outsource Your Quality Assurance?

Reduce Operational Costs

No need for an in-house QA team

Stay Compliant

Ensure compliance with ISO 13485, MDR, IVDR & FDA QSR

Access Industry Experts

Work with qualified QA professionals

Focus on Core Business

Let us handle QA management, audits & compliance

Scalable Solutions

Tailored to your business needs

Our Quality Assurance Outsourcing Services

Quality Management System (QMS) Implementation & Maintenance

  • ISO 13485:2016 & EN ISO 13485:2021 certification support
  • Development & maintenance of QMS documentation
  • Internal audits & gap analysis
  • Supplier & third-party audits

Regulatory Compliance & Audits

  • Compliance with EU MDR 2017/745 & IVDR 2017/746
  • MDSAP & FDA 21 CFR Part 820 audit preparation
  • Notified Body & Competent Authority audit support
  • Corrective & Preventive Actions (CAPA) management

Document Control & Process Management

  • Standard Operating Procedures (SOPs) creation & updates
  • Technical File & Design Dossier maintenance
  • Risk Management (ISO 14971:2019) compliance
  • Post-Market Surveillance (PMS) & Vigilance support

Supplier Quality Management

  • Supplier audits & qualification
  • Supplier risk assessments & monitoring
  • Corrective actions for non-compliant suppliers

Training & Continuous Improvement

  • ISO 13485 & MDR/IVDR regulatory training
  • Internal auditor training
  • CAPA & root cause analysis training
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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