About The Medical Device Internal Auditor Service

Posted by Thomas Regulatory Resolutions on September 3rd, 2019

Medical device manufacturers are required to perform regular audits of their ISO 13485 compliant Quality Management System (QMS). Internal audits support the safety and effectiveness objectives of the products they sell and ensure that an adequate, effective quality system is established and maintained. Your quality staff can perform these audits, but a professional, third-party auditor is more objective when assessing the status of your QMS and processes. Medical device services are conducting fully independent quality system reviews for companies with ISO 13485 certification.  It is approaching the initial ISO 13485 certification audits by a Notified Body or Registrar.

           Medical  Device Quality Management System Of  ISO 13485 Auditor Services

An ISO 13485 Medical Device Internal Auditor services help determine the actual status and health of your current QMS and processes. The purpose of quality audits is to ensure that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485. There are  ISO 13485 audit includes:

• An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
  
  
• A systematic and independent process audit to determine conformity or nonconformity of your medical device quality management system to ISO 13485:2016 requirements.
  
  
• Your internal review and external documentation to verify requirements have been addressed.
  
  
• The audit requirements are actual verification of ISO 13485 and through a review of the objective evidence.
  
  
• Physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met.
  
  
• The evaluation of the current special is controlling and validated processes. Medical Device Internal Auditor services are knowledgeable in various processes such as sterilization, clean rooms, or software systems.
  
      FDA Warning Letters
  
  
• This is identifying the violation such as poor manufacturing practices, problems with claims or incorrect directions for use.
  
  
• The letter also creates clear and the company must correct the problem. It provides directions and a timeframe for the company to inform the FDA of its plans for correction.
  
  
• FDA is checking to ensure and the company’s corrections are adequate.  Matters are described in FDA warning letters and it has been subject to subsequent interaction between FDA and the recipient of the letter.
  
  
• FDA warning letters may have changed the regulatory status of the issues discussed in the letter.