Overview HTSE provides automation and validation solutions for the medical device industry. We possess a thorough understanding of regulatory compliance requirements for medical device manufacturing processes and facilities. HTSE has medical device industry experienced engineering staff that can lead and execute validated projects. We understand the deliverables of a regulated industry project and have the requisite experience required for the development of automated manufacturing systems along with the generation and execution of:
Validation Master Plans
Factory Acceptance Tests
Controls / Automation Qualifications
Computer Systems Validation
Disaster Recovery Procedures
HTSE offers proven successful project methodologies that comply with Current Good Manufacturing Processes (cGMP). We possess a broad spectrum of regulated industry experience to control and qualify your systems and equipment.