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Encore Insights


  • Encore InsightFDA Consulting
  • FDA RegulationsRegulatory services for manufacturers
  • Expert Knowledge of Device Regulation
  • Import/Export Expertise
  • On-site FDA training
Encore Insight1 FDA Regulations2 Expert Knowledge of Device Regulation3 Import/Export Expertise4 On-site FDA training5

 

Encore Insight, FDA Consultant

Specializing in Regulatory Affairs

 

Encore Insight offers an ex-FDA senior manager’s experience that started his career as an FDA investigator and conducted factory inspections and investigations.  Many of his inspections resulted in extensive 483s, Warning Letters, Seizures, Injunctions and litigation.  You can reap the benefit of his experience rather than live in fear of enforcement actions that may loom in your future.

Services

 

Medical Devices

  • Quality System Regulation

  • Reports of Corrections and Removals

  • Medical Device Reporting

  • Remarketers/Servicers of Devices

  • Compliance issues and operation

  • Promotion and Advertising

  • Labeling

  • Software: Cybersecurity, Mobile Apps, Classification

  • Investigational device

FDA Wide Expertise

  • Factory Inspections

  • Responding to a 483 (list of inspectional observations)

  • Responding to a Warning Letter

  • Imports  (FDA and U.S.  Customs and Border Patrol)

  • Exports

  • Recalls

  • Informed consent


 Mr. Casper Uldriks
Mr. Casper Uldriks

 
  More Information

Quarterly Blog: Cap's Twist on the FDA


Contact Encore Insight

Encore Insight LLC
Casper E. Uldriks

3003 Van Ness St. NW, Apt S920
Washington, DC 20008
casper.uldriks@gmail.com
Tel: (202) 664-2077
Fax: (202) 733-1674
.


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© 2015 Encore Insight
Web site by Marc Nathan and Simply Computers Plus