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- Medical Device Consulting, 60+ Company Experience:
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Medical Devices Consultant

Medical Device Consulting and Resource Periodicals

regulatory consultant

Medical Device Entrepreneur & Inventor

  • Julia S. Rasor is a medical device consultant with both broad and deep multifunctional expertise;
  • Uses tools developed from a 60-company experience repeatedly proven effective for cost-effective problem solving: 'Rasor Resource Newsletter' shares these valuable proven tools with Medical Device Executives;
  • Methods have repeatedly proven effective in putting companies on the 'Fast Track';
    • Solving business, clinical, and regulatory hurdles
    • Innovating
    • Identifying and designing around pitfalls
    • Expediting product clearance
    • Optimizing the revenue ramp
    • Obtaining funding
    • Meeting BOD milestones
  • Serial entrepreneur/start-up CEO;
  • Adviser to start-up CEOs;
  • Inventor of a $100M/year revenue medical product, first ultrasonic contrast agent;
  • Author of over 20 White Papers yielding increased sales, venture funding, and FDA acceptance of proposed approaches;
  • Speaker at numerous universities and industry conferences;
  • Track record of 100% success with FDA;
  • Julia has combined her business and scientific expertise with her artistic innovation to produce fine art that is uniquely designed to amplify and distinguish a company brand, www.ModeArtGlobal.com.
    Facebook   View Julia S. Rasor's LinkedIn profile 

Innovative Fine Art for Corporate & Residential Branding

Innovative Fine Art for Corporate & Residential Branding, ModeArtGlobal.com

MODE Art Global produces innovative high-impact fine art for large corporate and residential projects worldwide. MODE is exceptional – we combine our business and scientific expertise with our artistic innovation to produce fine art that is uniquely designed to amplify and distinguish a company brand:
  1. MODE produces fine art from products or materials that our client companies manufacture resulting in novel branded artworks. Depending on the materials, this can be the final artwork or it can be memorialized in bronze or other archival material;
  2. MODE specializes in scale by providing artwork number, size, and material options using the latest state-of-the-art technology. Any number or size (keychain to monumental) of a particular sculpture can be produced using traditional or environmentally sustainable materials.
We work with business management, architects, and designers to formulate artwork that will elevate interior and exterior spaces and with art directors to add impact to entertainment and fashion industry events. Branded fine art has the power to transform any environment and leave positive and lasting effects on clients as well as employees in corporate and commercial environments.

Consulting Services

Business/ Management

  • Turnaround, Troubleshooting
  • Fundraising Assistance, Venture Capital, Angel
  • Opportunity Assessment, Due Diligence
  • Interim Executive Management, CXO
    • Chief Executive Officer (CEO)
    • Chief Science Officer (CSO)
    • Chief Strategy Officer (CSO)
  • Prudent Cash Management Strategy
  • Cross-Functional Big Picture Strategy
  • Entrepreneur, Founder, Start-up CEO
  • Board of Directors (BOD)
  • Business Model
  • Market Research, Product Line-up
  • Bass Diffusion Modeling of Revenue Forecast
  • Customer Research, Surveys
  • Competitor Research
  • Business Development
  • Marketing, Increasing Sales
  • Project Management (PM)
  • Subcontracting/Subcontractor

Clinical/ Technical

  • Scientific Advisory Board (SAB)
  • Clinical Research Organization (CRO)
  • Research and Development (R&D)
  • Intellectual property (IP), Patents
  • Clinical Study Design, Data Analysis
  • Clinical Study Monitoring
  • Preclinical Study Design, Data Analysis
  • In Vitro Models
  • In Vivo Models
  • Data and Statistics, Bayesian and Frequentist
  • Medical Writing, White Papers, Publications


  • IDE, 510(k), PMA, ANDA, NDA
  • Liaison with FDA
  • Responses to FDA Questions
  • Gaining FDA agreement to new regulatory paths
  • Gaining FDA agreement to optimal endpoints
  • Global Regulatory Strategies


  • CAPA's
  • Quality System Regulations
  • IS0 13485
  • QMS Audits
  • European CE Marking
  • Technical Files
  • STED
  • Japan PAL
  • China SFDA
  • Sterilization
  • Canadian Licenses
  • Internal and Supplier Audits
  • FDA Mock Audits
  • 483 & Warning Letter Responses
  • ISO 14971
  • Validations
  • Design Control
  • Risk Analysis & Management
  • DHF Development
  • GMP
  • Resolving Consent Decrees
  • Drug Listing, Registration, and Master Files

Resource Periodicals

Rasor Resource Newsletters

Over the years we have discovered, and colleagues have shared, a plethora of useful tools we have utilized to assist clients, leading to results of pivotal importance. They can be downloaded for one dollar each in the Rasor Resource Newsletter section below.


Rasor Resource Industry Information

Timely information, events, and the principal's talk presentation and publication materials, that may be of interest to those in the medical device industry and to entrepreneurs, are available for download for one dollar each.