Assist in drafting responses to audit observations
The one stop solution for all Medical device and Pharmaceutical engineers with various job titles. We work with small medical device organizations through to global leading medical device and pharmaceutical organizations. We deal with various types of Manufacturing projects and also Internal and regulatory body audit resolution. We have hundreds of specialist consultants within our network and also on our payroll who reflects the needs of this highly dynamic and rapidly growing industry.
Our Engineers and associates are ASQ certified and experts in 21CFR, ISO and USP regulations. Our highly skilled healthcare professional’s work of projects related to manufacturing and quality. They also carry on validation projects and are wear multiple hats at the client with following job titles.
Manage the readiness program from filing to inspection and post market support
Assist in drafting responses to audit observations
Develop Remediation plans
Assist device manufacturers in their Quality Systems and develop a new Quality system
Design review, product transfer and new product Implementation
Documentation Trainings and also instructor led trainings
Evaluate Quality management system and audits
Identify SOP, WI, Quality Systems Gaps and perform remediation based on FDA guideliness
Test Method, Instrument, Equipment and Software Validation
