AAPS Pharma

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Whether you’re a hardware, SaMD or IVD company, from Class I to III, let AAPS Pharma help create a
winning strategy and navigate high-stake situations such as device filings, and quality and compliance
hurdles.

Our Services:

  • 510(k), De Novo and PMA submissions, including PMA Supplements
  • EU MDR/IVDR and CE marking
  • ISO 13485, ISO 14971, IEC62304
  • Health Canada Class 2, 3 and 4 medical device licensing
  • Companion Diagnostic 510(k) and PMA submissions 
  • IDE submissions
  • Regulatory compliance with key standards like ISO 13485 and FDA 21 CFR 820
  • MDSAP
  • Risk management, including hazard analysis, FMECA and FTA support
  • QMS building, gap analysis, and support
  • Internal audits and audit readiness