IVD Consultants

IVD Consultants is a full-service contract, consulting and clinical research organization (CRO) that specializes in providing a wide range of Regulatory Affairs, Clinical Affairs and Quality Assurance services to early-stage and established In Vitro Diagnostic (IVD) and Medical Device companies. For over 25 years we have successfully helped many In Vitro Diagnostic (IVD) and Medical Device companies achieve their goals.

IVD Consultants is committed to improving the diagnosis and treatment of disease and disorders by helping our clients bring novel and innovative In Vitro Diagnostic (IVD) and Medical Device products to market. We do this by utilizing our industry leading Regulatory Affairs, Clinical Affairs and Quality Assurance expertise to help our clients succeed in bringing their products to market in the shortest possible time frame.

Our services include:

* U.S. FDA 510(k), pre-IDE, IDE and PMA Submissions
* U.S. FDA Meetings and Negotiations
* Global Product Submissions/Registrations (i.e. Canada, EU, APAC, EMEA and LATAM)
* Clinical Study Design and Execution
* Project Management Leadership and Guidance
* Product Development Leadership and Guidance
* Quality System Development and Implementation
* Mock U.S. FDA Inspections
* U.S. FDA 483 Resolution
* U.S. FDA Warning Letter Resolution

Contact Information:
– IVD Consultants website: http://www.ivdconsultants.com
– Telephone: 608-692-7839
– Email: [email protected]

Company’s Keywords:

us fda 510 & pma submissions, global product approvals, clinical study design, execution, quality system development, implementation, global regulatory strategic development, project leadership, us fda 483 & warning letter resolution