Empirical Consulting LLC

The experts at Empirical Consulting will guide you through the sometimes confusing and daunting regulatory approval process. Services include:
– Testing methodology and protocol generation with acceptance criteria
– FDA and international regulatory support
– Sterilization and contamination validation and testing
– Device and package evaluation and distribution testing
– Quality systems creation and support
– Internal or supplier auditing
– Education programs and courses
– Literature research, patent searches, report and white paper generation

Company’s Keywords:

medical devices, 510 submissions, technical files, quality systems, internal auditing