Program/Project Management Services for design, risk, quality, regulatory and compliance needs that are lean and cost-effective

Verification & Validation Services including Computer Systems

Quality Management System Implementation, Improvements & Audits

Design History File (DHF) or Technical File (TF) Assessments, Creation, Update, Remediation & Improvement; Summary of Technical Documentation (STED) Preparation, Communication & Submission to Notified Bodies

Regulatory & Compliance Assessments,  and Remediation, Submissions for US and EU approvals

European Medical Device Regulation (EUMDR 2017/745) Compliance