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Regulatory Services

As Regulatory bodies and authorities seek to provide rapid time to market reliance upon Risk Management, Clinical Evaluation, and Post Market Surveillance and an organizations focus on Life Cycle management is a must.  We provide services and strategy to help our partners achieve their goals:
 

  • Clinical Evaluations (MEDDEV 2.7.1 Rev 4)
  • Human Factors (US, EN62366 & ISO 14155)
  • Post Market Surveillance 
  • Regulatory Submissions ( US 510(k) )
  • Full Site Audit services (13485 and FDA GMP)
  • Select Auditing of Technical Files (ISO 14971 - Risk Management & 62304 - Software Lifecycle)
Schedule a Conference call with us to see if we can be of service - it's free!
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