Driving medical device compliance & business Excellence.

Hours

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Category

Medical Service Organizations

Services/Products

The eriah group. LLC is a global regulatory affairs and quality compliance consulting firm with a focus on business Excellence that provides these services to the healthcare industry. The Company specializes in guiding organizations through the complex landscape of worldwide government medical device regulations along with ensuring the most efficient pathway for safe and effective medical products to the marketplace. Areas of expertise are AS follows: • global quality management system compliance. Redesign. Remediation and training. • design controls. FDA submissions. FDA compliance. CE mark. Worldwide regulatory affairs and clinical affairs. • audit preparation. FDA inspection readiness. And FDA 483 observations. Warning letter and consent decree responses. • risk management. M&A DUE diligence. OUTSOURCING. Contract manufacturing. Distribution. Supplier quality and project management. • business Excellence. TQM. Sustainability. Balanced SCORECARDS. KEY performance indicators and benchmarking.

Associations

Advanced Medical Technology Association,American Society for Quality,Japan/U.S. Collaboration-Harmonization By Doing,Medical Imaging and Technology Alliance,National Association of Investors Corporation and Cleveland Council on World Affairs,Regulatory Affairs Professionals Society

AKA

The Eriah Group, LLC

Other Link

http://theeriahgroup.com