Pega Medical Inc.

Regulatory Services

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Regulatory clearance of new medical devices is one of our strengths. Pega Medical Services’ strong technical background, coupled with a solid understanding of US-FDA and Canadian regulatory requirements, has been a key factor in submitting successful pre-market applications. Pega Medical is ISO 13485:2016 and MDSAP certified.

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Our regulatory services include:

  • US-FDA 510K submissions
  • Health Canada Medical Device License (MDL) Applications
  • Europe CE Marking
  • Expertise in South American regulatory issues