• State of the art systematic literature review
  
• Clinical development plan (CDP)
  
• Clinical evaluation plan (CEP)
  
• Clinical evaluation report (CER)
  
• Clinical investigation plan for pivotal study

• Defining clinical claims and best regulatory pathway in EU & USA
  
• Clinical condition (hydrocephalus) with multiple etiologies and numerous types of adverse events
  
• Literature creates an unclear picture of the clinical landscape

“Teodora demonstrated her ability to get up to speed fast by reverting within a couple of weeks with a thorough, well-researched, stand-alone piece of work which could then be used in many different clinical documents and with insight into our regulatory path and our device’s possible claims prepared for a regulatory audience.”

“[…] well-written pieces for our technical document file for European and US regulatory bodies: our literature review, clinical protocol, clinical evaluation, vigilance and performance goal documentation, the latter being critical for our sample size discussions with the FDA.”

• State of the art systematic literature review
  
• Clinical evaluation plan (CEP)
  
• Clinical evaluation report (CER)
  
• Summative usability study protocol
  
• Clinical investigation report for human pilot study

• The subject device was still under development and is significantly different from the standard of care ostomy bags
  
• Defining usability and clinical parameters to be measured
  
• Selecting best approaches to measure quality of life parameters
  
• Comparing clinical endpoints to the state of the art

“Teodora has been a valuable partner throughout this process. Her approach was structured, well thought through, and clearly grounded in a strong understanding of regulatory requirements. She worked efficiently, asked the right questions, and quickly gained an overview of complex development activities, making collaboration smooth and productive.”

• Templates for CEPs and CERs for hardware devices
  
• Templates for CEPs and CERs for software (including AI-based) devices

• Long-term thinking, to avoid changing templates again in several months
  
• Integrating requirements and guidelines from various sources (e.g. MDR, MDCGs, AI Act)
  
• Providing instructions that were comprehensive enough for less experienced medical writers, but not useless for experienced writers
  
• Avoiding redundancy between documents
  
• Suitability of template to different devices and device classes

“I really enjoyed working with Teodora. She is very knowledgeable and reliable, and she isn’t afraid to challenge when needed. She quickly grasps complex topics and translates them into practical solutions and high-quality deliverables. Teodora always delivers on time, and her communication is clear and proactive. I could always count on her, and I would absolutely recommend her as a consultant. In case there is an opportunity, I would be happy to work with her again.”