<h1 class="entry-title">Group: Internal Audits</h1>

– Director of Operations – Class II and III device Manufacturer

“…I am confident that your knowledge, contacts in FDA, and your ability to interact with [our] personnel were instrumental in getting our approval rapidly. Your ability to move the process forward on a timely basis is important to our business planning and commitments to our management group. In addition, getting products on the market rapidly […]

– Customer Service Supervisor – Class II & III device Manufacturer

“…Very patient and understanding – related well between different stakeholders and individual departmental issues – an absolute pleasure to deal with – extremely supportive of our objectives.  Extremely capable when navigating through the labyrinth of [company] business practices and providing concise solutions.  Assisted tremendously in encapsulating the core issues that needed to be resolved so […]

– 12-year veteran in various positions including Director of Quality

“…The systems you delivered are highly customized to meet our compliance requirements and business needs.  All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover:  1. Compliance and regulatory understanding, was/is not wide-spread.  2.  Having the skill sets and time to create Policies/Procedures/Work […]

– CEO – Class II device Manufacturer

“…The biggest value ComplianceAcuity brought to the table for us was communication.  Not only did ComplianceAcuity interface directly with FDA on our behalf, but more importantly ComplianceAcuity got everyone in our organization on the same page and moving in the same direction. ComplianceAcuity continuously showed their tact and experience in interfacing with our personnel, breaking […]

– CEO – Class II device Manufacturer

“…The bottom line is that, due to ComplianceAcuity’s efforts and user-friendly solutions, our longstanding quality system deficiencies and FDA-compliance issues were effectively resolved and now we are operational and in compliance today. We see our relationship with ComplianceAcuity as a “partnership” and will continue to rely on their experience and professionalism in the future. I […]