Regulatory Services

SQM, Inc. offers a wealth of knowledge regarding FDA Regulatory needs and provides reliable, on-target, and practical solutions through the following Regulatory Services: 

Regulatory Strategy
  • Product Strategy, 

  • Submission Strategy, and

  • Compliance Strategy

Risk and Hazard Management
  • Initial Risk and Hazard Analysis,

  • Fault Tree Analysis, and 

  • Failure Modes and Effects Criticality Analysis

Independent Validation and Verification
  • Unit, Integration, System, Acceptance Testing

  • Inspections, Analysis, Reviews

  • Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Retrospective Documentation Efforts
  • Retrospectively Document Specifications

  • Retrospectively Test

Validation Packages
  • Development, Manufacturing, and Quality Systems Support Products

  • Vendor Supplied Components or Products

Premarket Submissions
  • 510(k)s

  • Premarket Applications (PMAs)

  • Investigational Device Exemptions (IDEs)

  • Humanitarian Device Exemptions (HDEs)  

Compliance Problem Turn-Arounds
  • Interface with FDA

  • Assist with Responses to FDA Actions

  • Assist with Development of Compliance Plans

  • Assist with Implementation of Corrective Actions

  • Assist with Establishing Compliant Systems


SQM Inc. can provide various levels of support individually tailored

for your special needs!

Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f),, copyright SQM, 1997-2002, Last modified: November 18, 2009