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case study: udem atlantic (spring, 2026)

Situation

Situation

Situation

 UDEM Atlantic was expanding into North America to support medical device manufacturers pursuing EU MDR certification and CE Marking.
The organization needed structure, clear positioning, and repeatable processes to build an early-stage pipeline and engage the market effectively. 

Task

Situation

Situation

  • Build a North American pipeline and outreach strategy 
  • Create scalable processes for research, outreach, and meeting prep 
  • Develop materials to support certification discussions 
  • Establish relationships across manufacturers and regulatory partners

Action

Action

Action

  • Built and managed a pipeline of 2,000+ target manufacturers 
  • Designed research frameworks to assess company fit and readiness 
  • Developed outreach structure, messaging, and tracking systems 
  • Created playbooks and materials to guide certification conversations 
  • Led discovery calls and supported early-stage pipeline development 
  • Mentored a small team supporting research and outreach execution

Result

Action

Action

  • Established a structured foundation for North American market entry 
  • Improved consistency and quality of outreach and conversations 
  • Enabled more efficient pipeline tracking and meeting follow-up 
  • Strengthened relationships across manufacturers and ecosystem partners 
  • Positioned UDEM Atlantic for scalable business development

1/2

Services Provided

Services Provided

Services Provided

  • Led market research and EU MDR landscape analysis for North American expansion 
  • Built outreach strategy targeting medical device manufacturers pursuing CE Marking 
  • Developed structured pipeline and prioritization frameworks 
  • Established relationships across manufacturers, consultants, and testing labs 
  • Managed research and outreach workflows supporting a 2,000+ company database 
  • Led discovery calls and early-stage certification discussions 
  • Created playbooks and materials to guide certification conversations 
  • Implemented tracking systems for outreach, meetings, and pipeline visibility 
  • Mentored a small research and outreach team 

Deliverables

Services Provided

Services Provided

  • Market research outputs identifying target companies and readiness signals 
  • Pipeline tracking system covering 2,000+ manufacturers 
  • Consultant engagement playbooks and certification conversation guides 
  • Discovery call frameworks and meeting preparation materials 
  • Internal documentation addressing MDR pathways and common questions 
  • Outreach and follow-up frameworks for consistent engagement 
  • Presentation materials outlining EU MDR and CE Marking processes 
  • SOPs supporting repeatable pipeline and outreach execution

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