SWAT Solutions, Inc.

SWAT Solutions, Inc. is a Minnesota-based software quality assurance company founded in 1997, specializing in FDA validation and compliance services for medical device and pharmaceutical companies. The company has evolved from a general software testing firm into a focused quality services organization with particular expertise in FDA Software Validation and Performance Engineering.

The company offers four core service areas: FDA validation for quality system compliance and audit remediation, agile testing services, test automation for repeatable workflows, and performance/load testing for application scalability. SWAT delivers these services through both on-site staffing models and consulting engagements, allowing clients to choose the level of collaboration that fits their needs.

Led by President Dave Steingart since its founding, the company employs quality professionals who have made FDA compliance and software testing their career focus. The firm positions itself as Minnesota's most focused software quality services organization, with consultants who stay current with regulatory requirements and industry best practices.

Choose SWAT Solutions when you need established FDA validation expertise integrated into your medical device or pharmaceutical software development process. The company's 27-year track record and specialized focus on regulatory compliance make them suitable for organizations navigating FDA requirements or responding to audit findings.

Expect quality professionals who can work on-site at your facility or as a consulting team, with particular strength in performance engineering, agile testing methodologies, and building automated testing frameworks for regulated environments.

SWAT Solutions concentrates specifically on the medical device and pharmaceutical sectors of healthcare, addressing the unique software quality and validation requirements imposed by FDA regulations. The company's services center on helping manufacturers achieve and maintain compliance with FDA quality system regulations, particularly for software components in medical devices and equipment.

Their healthcare expertise focuses on navigating 21 CFR Part 11 and related FDA guidance documents, supporting companies through validation protocols, audit preparation, and remediation activities required for regulated medical products.

Medical device manufacturers or pharmaceutical companies requiring FDA-compliant software validation and quality assurance services. Organizations with on-site collaboration needs in the Minneapolis-St. Paul area or those seeking consultants who understand the intersection of agile development and regulatory requirements. Companies facing FDA audits or building quality systems from the ground up.