case study: udem atlantic (spring, 2026 - present)

UDEM Atlantic is an international Notified Body supporting medical device manufacturers seeking EU MDR certification and CE Marking for access to the European market. As the organization expanded North American outreach, there was a need to build structured market development, strengthen consultant relationships, and create repeatable processes for engaging manufacturers preparing for certification. 

• Develop North American pipeline development and market outreach strategy for medical device manufacturers preparing for EU MDR certification.
• Build structured research, outreach, and meeting preparation processes to support scalable business development.
• Strengthen relationships with regulatory consultants, testing laboratories, and medical device manufacturers. 
• Create internal playbooks, materials, and training resources to support consultant discussions and certification conversations.
• Lead discovery meetings with companies exploring European market access and CE Marking pathways.

• Built and maintained a pipeline of 600+ North American medical device manufacturers evaluating international expansion.
• Managed and mentored a 2-person research and outreach team, overseeing prospect research, outreach preparation, and meeting coordination.
• Led 1–5 virtual discovery meetings per week with manufacturers and regulatory consultants exploring MDR certification.
• Developed Consultant Engagement Playbooks and supporting materials to structure discussions around certification scope, timelines, and engagement models.
• Created research frameworks to identify target companies, regulatory readiness, and certification needs.
• Implemented structured tracking for outreach, meetings, and pipeline development.

• Established a structured North American outreach and pipeline development framework for UDEM Atlantic. 
• Improved consistency in conversations with consultants and manufacturers preparing for MDR certification.
• Strengthened early partnerships with regulatory consultants and testing organizations supporting medical device companies.
• Enabled more efficient meeting preparation and follow-up through playbooks and repeatable processes.
• Positioned UDEM Atlantic as a trusted certification partner for manufacturers pursuing EU market entry.

• Led market research and regulatory landscape analysis for EU MDR certification and CE Marking readiness.
• Built North American outreach strategy targeting medical device manufacturers preparing for European market access.
• Developed structured pipeline development processes for identifying and prioritizing certification opportunities.
• Built relationships with regulatory consultants, testing laboratories, and medical device manufacturers.
• Managed research and outreach workflows supporting a 600+ company prospect database. 
• Led 1–5 discovery meetings per week with manufacturers and consultants evaluating certification pathways.
• Developed consultant engagement materials and internal playbooks for certification discussions. 
• Implemented structured tracking and reporting systems for outreach, meetings, and pipeline visibility.
• Managed and mentored a 2-person research and outreach team.
   

• Market research reports identifying target manufacturers and certification readiness signals.
• Pipeline tracking systems covering 600+ North American medical device companies.
• Consultant engagement playbooks outlining collaboration models and certification process stages.
• Structured discovery meeting frameworks for manufacturers and regulatory consultants. 
• Internal guidance documents addressing common MDR certification and pricing questions.
• Outreach and follow-up frameworks supporting consistent business development conversations.
• Presentation decks explaining EU MDR certification journey and CE Marking pathways. 
• Process documentation and SOPs supporting repeatable outreach and pipeline development.