What do we do exactly?
RoMonics is a Medical Device consulting group specializing in point-of-care-test (POCT) programs. Located in the Rocky Mountain Region, Colorado we provide assistance in the development of rapid tests for human and animal diseases.
Roy Mondesire, PhD
5343 Pinehurst Court
Boulder, CO 80301
FDA & ISO
regulatory issues, 510(k) submissions, CE Marking requirements
510(k), IDE, PMA Submissions
Device Import/Export Consulting
Medical Device Directives (CE Marking) Consulting
A. Study Design and Protocol Preparation
B. Pre-Submission Fulfillment (Pre-IDE, IDE-clinical trials, 510k or PMA submissions)
C. Medical Devices Directive (CE- Marking) Submission Process Fulfillment
D. Single or Multi clinical trials selection
E. Coordination of all Clinical Trial Project Activities
» Protocol preparation and all study specific documentation;
(case report forms, IRB submission, etc)
» IRB and ethics committee compliance and submission
and coordination of investigator sites
» Facilitate and negotiate investigator contracts
» Coordinate centralized services (E.g. Laboratory services)
» Prepare and monitor Sponsor administrative duties and checklists
of Study brochure and investigator training material
» Pre-study visits;
of clinical site, documentation of site, pre-study training of personnel)
» Study Initiation (conduct formal investigator’s meeting, review documents, training)
Study Monitoring and Termination
» Assess protocol adherence and regulatory compliance, review source documentation, etc.
» Prepare compliance reports, etc.
» Study termination
Data Analysis and Reporting
» Data Analysis (statistical and clinical)
» Report preparation and review