Regulatory Support
ENEM Consulting
ENEM Consulting

Comprehensive Solutions

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 with no prior regulatory precedent and execution. For platform technologies, ENEM Consulting can develop a plan for a phased launch of multiple applications, leveraging relevant pre-clinical and clinical history in the context of sequential submissions

Regulatory Strategy

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

Regulatory & 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 pre-clinical 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.
ENEM Consulting

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

Combination Products


International Submissions

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


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

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.

ENEM Consulting