In the News
FDA issues new RUO product guidance

FDA has issued a new guidance specific to RUO products.  MDC can assist you in understanding this new guidance and how it may impact your company.

MDC Associates’ three-tier Regulatory Consulting services offer clients expert guidance and support assuring that all regulatory needs are being met.

In the News
MDC assists clients in obtaining 510(k) clearance

Within the last 3 months, MDC has assisted clients in obtaining 510(k) clearance for new state of the art products including:

  •  Automated molecular assay for the detection of C. difficile
  •  Automated molecular assay for the detection of Flu/RSV
  • Automated molecular assay for the detection of Van R
  • Automated innovative system for the rapid identification of bacteria