onQ Management Consulting LLC

onQ Management Consulting LLC, with an industry leading consultanting team, will provide you a one stop shop for Quality & Regulatory services. Medical Device Consulting Services offered: -Quality & Regulatory Strategy development -Organizational & Leadership development: Analysis, planning and structure development. -Regulatory compliance to FDA & global MOH requirements: development and implementation of quality management systems compliant to ISO13485, FDA QSR, CMDR, ANVISA etc. Includes development of corporate policy and system to deploy down to the division, regional, and local level: -Design Controls Program -Production and Process Controls Program -Purchasing Controls / Supplier Quality -Service Quality Program -CAPA -Complaints Management / Adverse Event Reporting -Management Responsibility / Review -Compliance audits and gap assessments to FDA QSR and global regulations -483 / Warning Letter / Consent decree remediation planning & support -Risk Management program (ISO14971) -Product quality and reliability improvement utilizing six sigma tools -CE marking to market products in the EU -Process Validation -Six Sigma / lean program development and deployment -Recall strategy, planning and resourcing -Acquisition Due Diligence, planning and integration (Quality & Regulatory) -US FDA Agent Representative in US for companies with no US presence -Quality system tools and IT integration -Board of Directors support in Quality and Regulatory Compliance matters -Retainer services -Strategic Analysis (SWOT): Failures in the area of regulatory compliance, product quality and quality systems. -Business Development: Provide sales / business development support to other Medical Device Consulting businesses that need this type of service.