Regulatory Support

ENEM Consulting provides comprehensive, worldwide regulatory solutions for medical devices, IVDs and combination products. ENEM Consulting has a successful track record of developing a viable regulatory strategy for products that have no prior regulatory precedent and, executing on the same. For platform technologies, ENEM Consulting can develop a plan for a phased launch of multiple applications, leveraging relevant preclinical and clinical history in the context of sequential submissions.

Regulatory Strategy

Services include defining regulatory strategy for US and international market launch, including device classification and path to market.


Regulatory and Project Planning


Services include translating regulatory strategy into a project plan, including pre-clinical and clinical deliverables

  • Defining requirements for product development as required by FDA and ISO Quality System regulations
  • Guidance on preclinical testing (bench, animal) based on FDA Quality System requirements (QSr), ISO, IEC and other applicable software, electrical, EMC, safety, biocompatibility, sterilization, packaging, shipping and industry standards
  • Defining regulatory requirements for clinical studies based on Good Clinical Practice (GCPs), ISO 14155 & IDE regulations

Regulatory Submissions


Services include developing submission template/table of contents, writing, reviewing, editing of submissions. It also includes assisting with FDA, Regulatory Agency and Notified Body communications through the submission review process.


     FDA Submissions:

  • PMA: Original, Modular and PMA Supplements
  • Original IDE and IDE Supplements
  • 510(k): Traditional, Abbreviated and Special 510(k)s
  • HUD and HDE applications

     International Submissions:

  • CE Mark: Technical files and design dossiers
  • Health Canada and Japan PMDA applications

      Combination products:

  • IND/IDE
  • NDA/PMA

       IVDs:

  • 510(k)s, PMAs for High Complexity kits
  • CMS’ CLIA, NY and other state agency requirements

FDA Communication & Submission Management


Services include assistance with FDA meetings, teleconferences and FDA Panel meeting support. Also includes guidance on pre-IDE meeting strategy, support with presentations and as your liaison with FDA through the pre-IDE review process.


Due Diligence


Services include independent regulatory appraisals of potential acquisition, diversification and licensing candidates.