QQMS Compliance

The US Food and Drug Administration (FDA) requires medical device manufacturers to implement quality systems in accordance with the Quality System Regulation (QSR) per 21 CFR Part 820, formerly known as Good Manufacturing Practices (GMP). Manufacturers, specification developers, contract manufacturers, relabelers/reprocessors, and even some distributors must implement a quality system compliant with the QSR.

Medical device and IVD manufacturers must conduct internal audits of their quality management systems in accordance with the Quality System Regulation (QSR). Failure to conduct an internal audit can result in product quality issues, lack of process improvements, or regulatory compliance issues. Emergo can perform independent internal compliance audits on behalf of clients to determine quality system compliance, particularly for clients lacking the resources or experience to perform their own audits.

Our expert team can help in performing

  • Gap Analysis Audit
  • Supplier Quality Audit
  • Design History File
  • Risk Assessment and CAPA
  • FDA Pre-Inspection Audit
  • QSR Mock-Audit
  • Design Control