DESIGN & DEVELOPMENT

DESIGN CONTROL SERVICES

SEISA_Capabilities_Design&Development2

Design Control Services

SEISA’s design control services will make sure you are compliant with FDA CFR 820.30 and ISO 13485:2013.

SEISA’s first step is to create a gap analysis summary report by benchmarking your FDA CFR 820.30 practices and Design History File.

SEISA uses its findings to offer support in document development for project and V&V plans, design input and output, risk analysis, FMEA analysis, as well as design control systems.

SEISA’s Shared Commitments to Customers

Regulatory-focused culture: FDA-registered, ISO-certified

Lean initiatives to drive savings and improvements

Scalability to meet any market demand

Seamless customer care communication