Medical Device Directory

Remediation: Quality Systems & Products

Available from Optim Associates, Inc.

QS Remediation Defined: Quality Systems Remediation is the process of recognizing change is necessary, identifying systemic issues, performing Root Cause Analysis, creating a plan—or plans—for immediate correction and future prevention of the resurfacing of the issues and then execute to the plan(s).

Product Remediation Defined: While QS Remediation is about re-designing procedures and processes, many times the objective evidence proving fielded products are safe and effective is less than inadequate. OPTIM Associates has a long history helping focus efforts and resources on the essential evidence required to back-fill the necessary design and manufacturing evidence.

OPTIM Associates Value: OPTIM Associates recognizes that during any FDA Enforcement Activity, one of the challenges is to remediate the fielded products that continue the revenue stream while meeting baseline and heightened regulatory scrutiny. OPTIM Associates recognizes what key elements of product characterization are most important for re-establishing safety and effectiveness.

OPTIM Associates recognizes that “time is money” and companies needing QS Remediation—483, Warning Letters, Consent Decrees, Import Detentions—did not get there overnight…rather many years of sub-optimal decisions throughout the company at all levels. Identifying and modifying key decisions along with changing organizational behaviors to meet regulatory compliance expectations is crucial to quick and effective QS Remediation.

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