Description:
An in-depth analysis and assessment of your organization’s current status against the ISO 13485 standard. Each applicable requirement of the standard is assessed, and a Report is issued describing specific areas or “gaps” in your current system. The report includes recommendations on how to effectively address these “gaps,” as well as a realistic time-line for registration.
Who Will Be Involved?
Depending on the size of your organization and the scope of the proposed certification, most individuals, process owners, and departments within your organization will be participating in the Gap Analysis Assessment. Brand Consulting Group will provide you with a detailed Assessment Plan and Schedule prior to our visit which will include the individuals, departments, and time needed to complete our assessment.
Duration:
Varies depending upon the size, complexity, and scope of the organization and processes being assessed.
Type: On-Site Assessment
Price: $1200/auditor/day-Consultant, $2000/auditor/day-Senior Consultant
Brand Consulting Group uses only certified IRCA auditors including at least one certified lead auditor for each Gap Analysis Assessment.