Put OPTIM Associates’ expertise to work in achieving regulatory compliance for your medical device.
Our regulatory experience includes engagements with Fortune 1000 companies to provide Quality Systems and detailed regulatory / engineering guidance for Class II and Class III medical device designers and manufacturers.
- Dental Implant Design / Mfg., (Palm Beach Gardens, FL, 2014-present): Pro-Active FDA Warning Letter Remediation Response. Design Controls / Risk Management Remediation. Develop Interim Controls, Corrections and Containment Plans. Address external and FDA audits.
- Infusion Pump Design / Mfg., (Lake Forest, IL, 2013-2014): FDA Warning Letter / Import Detention. CAPA Remediation. Develop Interim Controls, Corrections and Containment Plans. Address external and FDA audits.
- Sterilization Products Design / Mfg., (Irvine, CA, 2012-2013): FDA Warning Letters.. Product Risk Management File correction and Design History File assessments Preparation for external audit readiness.
- Visit our Project Page to review more of our successes.