Providing consultation for the development, manufacture and commercialization of medical devices and diagnostic kits under FDA, GMP and ISO requirements. Extensive experience in operations with an emphasis on manufacturing, supply chain, facilities and quality for startups to Fortune 500 companies.
Highly skilled in technical project management involving multi-disciplinary teams, establishing and negotiating US/OUS operations/partnerships, quality system implementation, troubleshooting, resource utilization, capacity planning and COGS reduction. Hands-on, with broad communication skills from the shop floor to board members.
Services provided:
Manufacturing – scale-up, outsourcing (US and OUS), cost reduction.
Supply Chain – establishment, supply agreements, cost reduction.
Facility – leases, expansion, decommissioning, organization (5S).
Quality – documents, audits.
Merger and Acquisitions – operation evaluations to include COG’s, materials, manufacturability, scale-up.
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