Solutions
We offer personalized support and effective solutions for your regulatory compliance and internal processes.
Gap Identification
We analyze your processes to identify and close gaps in regulatory compliance.
Personalized Support
Our team is ready to step in and provide assistance when you need it most.
Flexibility in Solutions
We implement an agile process that allows us to quickly adapt to your changing needs.
Effective Solutions
We identify gaps and chart effective paths for you.
Personalized Support
Quick and effective intervention in your compliance projects.
Continuous Assessment
We monitor and adjust your regulatory compliance processes.
Agile Flexibility
We tailor solutions to meet your specific needs.
Comprehensive Preparation
We ensure your team is prepared for any challenge.
Comprehensive End-to-End Project Support
We provide a structured and seamless approach to your projects, covering every phase from pre-work and kick-off meetings to process verification and regulatory documentation.
Project Preparation: Developing SOWs, quotes, and BOMs while ensuring alignment with customer requirements (Specs and CTQ).
Tooling and Equipment: From design and programming to acquisition and installation, including molds, fixturing, and prototyping.
Validation and Qualification: Covering FAT, SAT, installation, and operational/process qualifications, as well as master validation plans.
Manufacturing Readiness: Process flowcharts, manufacturing layouts, line readiness, and test method validations.
Process Optimization: Characterization studies, calibration, and preventive maintenance to enhance efficiency.
Regulatory Compliance: Comprehensive documentation including MVP, Quality Plans, PFMEA, DHR/eDHR, and risk assessment plans.
With our agile and adaptable support, we ensure your projects are completed on time, within scope, and aligned with the highest standards of quality and compliance.
Lean Tech Concepts transformed our regulatory compliance, providing effective solutions and exceptional support
Michael Walker
★★★★★