From Design Control to Validation, from Production Control to Complaint Handling and Corrective Actions, we offer a wide range of quality assurance services to meet Federal and international requirements. We can help you develop and implement a right-sized quality assurance program to meet FDA and ISO 13485 requirements.

Design Control:

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 during 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? Do you want to have a mock FDA audit or gap analysis to ensure your system and records are acceptable? We have conducted over 400 corporate quality system audits. We have the experience to show you where there may be problems and recommend solutions.

Supplier Qualification:

The FDA and ISO are looking to see that you have qualified your supplier. Simply stating that they are ISO certified, FDA registered, or work with that “large international medical device company” will not suffice. In many cases, critical suppliers must be audited. We can conduct audits to help you maintain compliance and ensure that compliant products are delivered to your company.

Having performed over 300 compliance audits, Boulder BioMed can be your supplier auditor, reducing overhead costs and ensuring compliance.

Our services include:

  • Quality systems SOP documentation development
  • Complaint and MDR reporting
  • Quality system training
  • Quality supplier audits
  • Quality system audit & remediation
  • Risk management & mitigation
  • Retrospective design history
  • Outsourced Quality Assurance (OSQA)