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Obelis European Authorized Representative Center

"CE Marking Consultants with a Reputation for Excellence"

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USA: MDC Associates

[ 163 Cabot St.Beverly, MA 01915 ]

t. +1 978 927 3808

e. info@mdcas ...

MDC Associates is committed to working closely with clients, providing affordable and effective market research and regulatory consulting services with over 30 years of combined experience in both the medical device market and the regulatory environment.  MDC offers a unique combination of services that help clients develop successful marketing strategies.
Services Include:

  • Register company with FDA
  • Prepare facility and documentation required for FDA, QSR, cGMP and ISO 13485 compliance
  • Monitor quality systems for continual regulatory compliance
  • Develop and conduct regulatory training programs
  • Prepare pre-market submissions
  • Conduct facility audits
  • Conduct clinical trials
  • Develop clinical trial protocols
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