Standards and Regulatory Experience

Regulatory

We have deep experience with FDA regulations and guidance (21 CFR part 820, 510(k) and PMS submissions, FDA inspections, etc.)  We understand the Medical Standards including:

  • ISO 13485
  • ISO 14971
  • IEC 60601 series including numerous collateral particular standards
  • IEC 62304.

In addition, our staff has experience in compliance with 3rd edition IEC 60601-1 harmonized standards with over 100 clauses that require risk analysis specific to the medical device.  We have performed safety risk analysis per ISO 14971, developed software per IEC 62304 and performed usability analyses per IEC 62366.