Service Descriptions

Consulting Services:  Two Harbors Consulting understands the needs of your organization are unique, and therefore require solutions specifically tailored to your needs at this time.  With decades of experience over multiple industries, and use of both industry standard and innovative tools and techniques, we can assist your organization in true value added fashion – be it the definition of goals and objectives for your organization, facilitation of Agile/Lean transformations, identification of product and process risk, development of a new program or service, better managing your supply chain or DevOps, or effectively managing your next acquistion – Two Harbors is here to partner with you.

Medical Device and Drug Regulatory Consulting Services:  Quality or compliance?  Why not both?  Our goal in working with your organization is to aid you to identify and determine compliance with applicable regulations and standards, evaluate actual adherence to the processes described in your quality system, detect potential quality issues, and to assist you with defining and implementing solutions that address compliance, quality with a clear understanding of business value add.  Typical standards and regulations include 21 CFR 803, 806, 807, 820, 830, 210, 211, ISO 13485:2016, ISO 9001:2015 and ISO 14971: 2019