Sign up for our
News Feed

Experience….

   

 

We are consultants to:
  • Start-up companies and Fortune 500 companies
  • Privately and publicly held companies
  • Therapeutic medical device companies
  • In vitro and in vitro diagnostic device companies
  • US, EU, and Japanese-based companies
  • Consulting organizations
  •  

    We are trainers to:

  • Government agencies, including FDA
  • Consulting organizations
  • Start-up, privately and publicly held companies
  • Therapeutic medical device companies
  • In vitro and in vitro diagnostic device companies
  • US, EU, and Japanese-based companies
  •      

    We perform these services...

  • Biocompatibility
  • Biological safety
  • Marketing analysis
  • Competitive intelligence
  • Marketing intelligence
  • CRO services, including
  • Sample size calculations
  • Protocol design and review
  • IDE applications
  • Monitoring
  • Database design per Part 11
  • Data entry
  • Statistical analysis of data
  • 510k or PMA regulatory applications
  • Sponsor and site audits
  • Registry studies or trials
  • Post-approval studies or trials
  • Training, seminar, webinars, eConferences
  •  

    And we have worked with these technologies...

  • Blood and hemostatic agents
  • Blood dialyzers and filtration devices
  • Breast implants
  • Cardiovascular devices
  • Dermal contact products
  • Diabetics devices
  • Disposable products
  • Implantables
  • Injectables
  • In vitro diagnostics
  • In vivo diagnostics
  • Imaging devices
  • Electrical stimulation devices
  • Embolism treatment devices
  • Endoscopic equipment
  • Eximer lasers
  • Extracorporeal oxygenators
  • Gastroenterology imaging devices
  • Gynecological devices
  • Muscle stimulation devices
  • Nanotechnology detection
  • Oncology diagnostics
  • Orthopedic implants
  • Oxygen monitors
  • Precision surgical equipment
  • Respiratory support devices
  • Spinal Disc implants
  • Thermal treatment devices
  • Ultrasound devices
  •  

     

    Related topics:  statistics, sample size, biostatistics, equivalence, equivalent, better than, claim, performance, safety, efficacy, blackwelder, statistical plan, database design, data entry, double, Part 11, hypothesis, ISO 14155, EN 540, project management, sponsor, protocol, literature, investigator brochure, Cochrane Library, research, study, trial, studies, response variable, endpoint, case report form, investigator, site, center, technical writer, FDA, CDRH, 510k, 510(k), premarket notification, , IDE, investigational device exemption, PMA, premarket approval, submission, approval, biomedical, corporate inteligence, medical market, corporate spy, SCIP, competitive inteligence.