Medical Device Quality and Regulatory Compliance
FDA (cGMP/ QSR), ISO, MDD and Remediation
Ever wonder why companies face recurring problems (CAPA or customer complaints), and why production and process controls, management responsibility, controls, etc., continue to show up on Warning Letters?
Medical Device Regulatory Compliance
Engineering / Manufacturing Process Validation Consultants
Eliminate regulatory remediation results - FDA 483s or Warning Letters - Achieve a compliant, effective & efficient Quality Management System - diagnose, develop, implement, validate and quantify critical business process effectiveness.
Product Development Services and FDA Requirements / Proven Reduced Time-to-Market
Getting new product into market quickly and effectively is the key to success. Developing product consistent with FDA requirements while not slowing the R&D effort is a tricky business; if the system is designed properly, you can have both.
Cost-effective Manufacturing Problem Solving Results in Exceptional Customer Service
Ever wonder why companies face recurring problems, missing deadlines & targets - costing time & money? Problems lead to recalls and potential regulatory actions...all avoidable. Cost-effective manufacturing results in exceptional service to your customers.