Additional Information
Creation of detailed URS/ERS documents
Technical interface matrices
Vendor audit and comparison scoring
FAT/SAT documentation support
Traceability to ISO 13485 and 21 CFR 820 requirements
We craft comprehensive Equipment Requirement Specifications (ERS) that define every mechanical, electrical, software, and regulatory expectation for your equipment suppliers.
Our structured ERS ensures vendors fully understand your process parameters, material constraints, automation interfaces, and validation deliverables before quoting.
We also manage vendor selection, using weighted scoring matrices to evaluate technical fit, compliance readiness, cost, and service capability.
This service reduces supplier misalignment, mitigates project delays, and ensures your capital equipment investments yield measurable ROI — all while meeting global regulatory standards.
We craft comprehensive Equipment Requirement Specifications (ERS) that define every mechanical, electrical, software, and regulatory expectation for your equipment suppliers.
Our structured ERS ensures vendors fully understand your process parameters, material constraints, automation interfaces, and validation deliverables before quoting.
We also manage vendor selection, using weighted scoring matrices to evaluate technical fit, compliance readiness, cost, and service capability.
This service reduces supplier misalignment, mitigates project delays, and ensures your capital equipment investments yield measurable ROI — all while meeting global regulatory standards.
Creation of detailed URS/ERS documents
Technical interface matrices
Vendor audit and comparison scoring
FAT/SAT documentation support
Traceability to ISO 13485 and 21 CFR 820 requirements