Field Inspection Services
Thorough on-site inspections to identify faults, verify system integrity, and ensure compliance with FDA regulations and medical device quality standards for manufacturing equipment and processes.
Ensure compliance, quality, and safety in medical device manufacturing with our comprehensive inspection services. Our ISO-9001 certified team delivers thorough on-site evaluations to identify defects, verify system integrity, and meet stringent FDA and regulatory standards. With over 35 years of experience serving precision manufacturing sectors, we understand the critical importance of quality control in medical device production where accuracy and compliance are non-negotiable.
Comprehensive inspection solutions ensuring your medical device manufacturing meets the highest quality and regulatory compliance standards.
Thorough on-site inspections to identify faults, verify system integrity, and ensure compliance with FDA regulations and medical device quality standards for manufacturing equipment and processes.
Advanced diagnostic services to identify equipment failures, calibration issues, and performance problems in medical device manufacturing systems, ensuring minimal downtime and consistent product quality.
Monitor and validate critical process parameters including temperature, pressure, and sterility controls to ensure stable operations and regulatory compliance throughout medical device production.
Comprehensive evaluation of PLC and automation systems controlling medical device manufacturing to verify proper operation, data integrity, and adherence to validated processes.
Protect sensitive manufacturing data and ensure HIPAA compliance with thorough security inspections of industrial control systems and network infrastructure in medical device facilities.
Detailed inspection reporting and documentation to support ISO 13485, FDA 21 CFR Part 820, and other medical device quality management system requirements.
Medical device manufacturing demands absolute precision and regulatory compliance. Our ISO-9001 certified inspection services provide the thorough evaluation your facility needs to maintain quality standards, meet FDA requirements, and ensure patient safety. With certified PE engineers on staff and over 35 years of experience in precision manufacturing sectors, we understand the unique challenges of medical device production—from cleanroom protocols to validation requirements. Our comprehensive inspections identify potential issues before they impact production, verify system integrity across automated and manual processes, and provide detailed documentation to support your quality management system and regulatory submissions.
Over three decades of delivering precision inspection services that keep manufacturing facilities compliant and productive.
Our comprehensive approach ensures your medical device manufacturing maintains the highest standards of quality and compliance.
Our certified quality management system ensures consistent, reliable inspection processes that meet medical device manufacturing standards and FDA expectations.
Certified Professional Engineer on staff providing expert-level technical evaluation and compliance verification for complex medical device manufacturing systems and equipment.
Since 1988, we've completed over 5,000 successful projects across precision manufacturing sectors, bringing deep understanding of quality-critical production environments to every inspection.
Detailed inspection reports with actionable findings, photographic evidence, and regulatory-ready documentation to support your quality management system, audits, and continuous improvement initiatives.
Dedicated professionals committed to your manufacturing success.
Since our founding in 1988, Lashley Cohen and Associates has built a reputation for excellence in industrial inspection and automation services. Our team of certified engineers and experienced technicians understands the critical nature of medical device manufacturing, where quality control isn't just about efficiency—it's about patient safety. We've grown from a small engineering firm to a trusted partner for manufacturers across the Southeast, completing over 5,000 projects and serving more than 2,000 clients. Our ISO-9001 certified processes, combined with our Rockwell Systems Bronze Partner status and certified PE engineer expertise, position us uniquely to serve the demanding requirements of medical device manufacturing. We approach every inspection with a proactive mindset, not just identifying current issues but uncovering opportunities to enhance your operations and align technical systems with your future business goals.
What standards do your medical device inspection services address?
Our inspection services are designed to support compliance with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485 (Medical Device Quality Management Systems), ISO 9001, and other relevant medical device manufacturing standards. We provide comprehensive documentation to support regulatory submissions and audits.
How often should medical device manufacturing equipment be inspected?
Can you inspect both automated and manual manufacturing processes?
What kind of documentation do you provide after an inspection?
Do you provide emergency inspection services?
Are your inspectors familiar with cleanroom protocols?
Can you help prepare for FDA inspections or audits?
What types of medical device manufacturing facilities do you serve?
Our engineering team is ready to discuss your specific medical device manufacturing inspection needs.
Quality management system certification ensuring consistent service delivery
Official partnership demonstrating automation systems expertise
Licensed PE engineer providing expert technical oversight
Complete the form below and our engineering team will contact you within one business day to discuss your inspection requirements and schedule.
For immediate assistance, feel free to give us a direct call at (770) 962-0878 You can also send us a quick email at websales@lashleycohen.com
For immediate assistance, feel free to give us a direct call at (770) 962-0878 You can also send us a quick email at websales@lashleycohen.com