Quality Assurance Consulting Services

Boulder iQ offers a wide range of services to help you meet federal and international requirements. We develop and implement a right-sized quality assurance program to meet FDA and ISO 13485 requirements. This includes design control to validation, product control, complaint handling and corrective actions.

Quality Assurance Consulting Services

Audits for Supplier Qualification

Boulder iQ will conduct audits to help you maintain compliance and ensure compliant products are delivered to your company. The FDA and ISO are looking to see that you have qualified your suppliers. Simply stating a supplier is ISO certified, FDA registered, or “work with a large medical device company” is not sufficient. In many cases, suppliers must be audited. Boulder iQ has performed over 300 successful compliance audits. Using this experience, we will act as your supplier auditor to ensure compliance and reduce overhead costs.

  • Quality Systems SOP Documentation Development
  • Complaint & MDR Reporting
  • Quality System Training
  • Quality Supplier Audits
  • Quality System Audit & Remediation
  • Risk Management & Mitigation
  • Retrospective Design History
  • Outsourced Quality Assurance (OSQA)
  • High Quality Systems

Are you having trouble with your design control system?
Let us review it and show you where we can help. We can develop a process that is effective and fits your company’s specific needs.

Does your product contain software?
Ensuring compliance with software development can be very difficult. The FDA guidance documents are very specific; missing information will lead to compliance and regulatory submission problems.

Do you need to perform a Usability Study?
We have human factor experts who can help with protocol development, implementation, FDA meetings, and report writing.

Do you have an upcoming ISO or FDA audit and want to confirm your compliance?
We have conducted over 400 corporate quality system audits. We can ensure if your compliance will be confirmed or not.

Do you want to have a mock FDA audit or gap analysis to ensure your system and records are acceptable?
We have the experience to show you where there may be problems and recommend solutions.