Process Automation & Machine Control
Inc.Medical Device
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:
- ASTM Validation
- Computer Validation
- Validation Master Plans
- User Requirements
- Functional Specifications
- Design Documents
- Factory Acceptance Tests
- Impact Assessments
- Installation Qualifications
- Operational Qualifications
- Controls / Automation Qualifications
- Computer Systems Validation
- Performance Qualifications
- Disaster Recovery Procedures
- SOP Development
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.
