Quality Management Systems

A properly scaled Quality Management System is often the difference between it being an asset versus a liability.  Integral Medical Device Consulting has successfully established and certified ISO-13485 and FDA 21 CRF Part 820 compliant QMS for startup medical device companies.  Whether you require a complete Quality system or merely need to strengthen a few key procedures, Quality consultants at Integral can help.

 

QMS Establishment and Certification

Working with your Regulatory team, Integral can help you define a strategy for selecting your notified body and leveraging your certification to obtain CE Marking or FDA approval (IDE, 510k, or PMA). Quality consulting from Integral is more than a set of documented procedures. It includes training of your staff, functional leadership, and establishment of a healthy culture rooted in product quality and integrity.

 

QMS Infrastructure

Integral Medical Device Consulting can deploy cost effective solutions for document control (Product Lifecycle Management), enterprise resource management (ERP), and technical services. Investing in robust systems to manage design history, lot traceability, training records, and complaint handling will help facilitate smooth inspection audits.