The success of our previous projects speaks volumes on what we can do for you.
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. Lead multi-site QSR Audits, Perform Gap Analysis, Implement QSR and Product Remediation Plans, Coordinate cross-functional projects in response to FDA Regulatory Actions: 483’s, Warning Letters, Import Detentions, Consent Decrees. Specific expertise—Management Controls, Training, CAPA, Hardware / Software Design / Development, Risk Management, Design Validations, Process Qualification and Validations, Production and Process Controls, Computer System Validations, and Post Market Surveillance and Support Systems, including Complaints / MDR’s.
- 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.
- Infusion Pump Design / Mfg., (Buffalo, NY, 2012): FDA Warning Letter.. Complaints Management, MDR and Risk Management System Remediation. Perform Assessment and gap analysis, develop and implement detailed implementation plan and act as interim Complaints Manager.
- Heart-Lung Design / Mfg., (Ann Arbor, MI, 2011-2012): FDA Consent Decree. Risk Management and Design Control Remediation. Perform Gap Analysis, establish integrated Risk Management program and train company personnel. Remediate on-market products.
- LASIK, Intra-Ocular Products Design / Mfg., (USA, Spain, 2009-2011): QSR Audit and Remediation. Lead QSR Auditor (3 sites), perform site Gap Analysis and implement Quality System and Product Remediation Plans.
- AED / Clinical Defibrillator Design / Mfg., (Andover, MA, 2010): Reliability Program / Product Assessment. Perform reliability program and product assessments.
- Orthopedic Implant Mfg., (Ohio, 2009): FDA Warning Letter QSR Follow up Audit. Executive Management Education.
- Blood Pressure Design / Mfg., (Michigan, Taiwan, China, 2008-2010): FDA Import Detention. Quality System and Device Gap Analysis and Remediation—Design Controls, Risk Management, Documentation Control, and Training systems.
- IVD, Glucose/Ketone/Cholesterol Analyzer Design / Mfg., (Indianapolis, IN, 2008): FDA Warning Letter. Quality Systems and Device Remediation—Design Controls, Risk Management, Documentation Controls, and Project Management.
- Telemedicine Design / Mfg., (McLean, VA, 2008): BSI Audit Preparation. QSR / ISO Audit. Quality System and Device records preparation for BSI Audit.
- Infusion Pump Design / Mfg., (San Diego, CA, 2007): FDA Consent Decree. Quality System and Device Remediation implementation—Design Controls, Risk Management, Product Root Cause Investigations and product corrections.
- Mobile Fluoroscopy System Design / Mfg., (Salt Lake City, UT, 2007-08): FDA Consent Decree. Quality System and Device Remediation—Design Controls, Risk Management, and Reliability.
- Hemodialysis Design / Mfg., (Modena, Italy, 2006): FDA Import Detention. Quality System and Device Remediation—Design Controls, Risk Management, Product Validation (HW/SW), DHF Remediation, HACCP, Product Root Cause Investigations and product corrections, and Interim Quality Management.
- Tissue Oximeter, (Champaign, IL, 2006): 510(k) Traditional Pre-Market Notification.
- US Army Vehicle Weapons System, (Sterling Heights, MI, 2004-05): Management and Technical Reliability Liaison between US Government Program Office and System Developer for Stryker MGS and Expeditionary Fighting Vehicle government programs.
- Legal Consultation, (Chicago, IL, 2005): Research Expert Witness for Class III medical device personal injury claim.
- AED / Clinical Defibrillator Design / Mfg., (Chelmsford, MA, 2004-06): Reliability Assessments and Program Development. Program development, implementation and execution for three new product development projects.
- Pharmaceutical / Medical Device Design / Mfg., (N. Chicago, IL, 2003-04): FDA Inspection Readiness. Corporate Metrology/Calibration Laboratory Validation remediation: hardware, software, utilities, facilities, processes, and methods. Develop and execute remediation plans and procedures for Laboratory IQ/OQ/PQ—integrate into existing Quality System.
- Dental Device Design / Mfg., (Franklin Park, IL, 2003): FDA Inspection Readiness. Quality Systems Remediation. Gap Analysis, Root Cause Analysis, Risk Assessments, CAPA Plans, Master Validation Plans, IQ, OQ, and PQ development and execution.
- Urology Stent Design / Mfg., (Racine, WI, 2003): Complaint and Field Failure Remediation. Root Cause Analysis and Process / Yield Improvement for manufacturing processes.