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I seek to provide services and immediate value to medical device manufacturers, supporting the following global enterprise objectives for all Class I–III medical devices:

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• Reducing barriers to market for global medical device submissions
  (Areas of operation: EU, US, UK, LATAM, Asia, Australia, Canada, Middle East)

• Pre- and post-market evidence generation strategies

• First-in approvals for clinical documentation (CEP, CER, PMCF, SSCP, PSUR)

• Technical documentation and Tech File assessment and alignment

• SOP and template development

• ISO 14971 risk management gap analysis and benefit–risk development support

• Clinical trial strategy and protocol development

• Assessment, building, and implementation of medical writing and post-market surveillance programs

• Clinical data gap analysis, data mining, formatting, and synthesis

• Audit support and Notified Body engagement

• Mergers & Acquisition - clinical support (gap analysis of technical documentation, Tech Files, and dossiers)​​

 

My philosophy in driving excellence in the medical device industry is rooted in trust-based leadership—solidified by integrity, mutual respect, clear and concise communication, and delivering projects on time and on target.

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P.S. It’s 2025—are you really still paying that much for CER development and getting that many Notified Body queries?