ISO 13485 & Regulators

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Paalan International has an in-house team of experienced and professional consultants capable of helping you with all elements of regulatory compliance required to bring your products to market. We provide a comprehensive range of consultancy services, including:

  • Technical Documentation Creation and Compilation.
  • Technical Documentation Review and Gap Analysis.
  • ISO 13485 QMS Setup / Internal Audit.
  • Bespoke Training Services.
  • Label and IFU Guidance.
  • General EU Consultancy.
  • Retained Quality / Regulatory Consultant.
CDSCO (Indian MDR)
CE Marking (EU MDR/IVDR)
US FDA 21 CFR Part 820
MDSAP