At every step of your regulatory affairs journey

Regulatory Scope Assessment (Design for Compliance)
   Regulatory requirement identifcation.
   Product-wise regulatory feasibility assessment

Regulatory Work Planning
  Risk-based classifcation
  Predicate device Reference identifcation
  Review of applicable Standards & Regulations
  Source File analysis and gap assessment.
  Review of clinical validation and safety testing requirements
  Pathway (Route) of Regulatory submission
  QC check mechanism

State of the Art
  Detailed gap assessment according to applicable standards
  Labelling design and content review.
  Remediation support

Regulatory Reviews
  Risk Management Files.
  CER and PER.
  DHF content.
  Promotional materials.
  Design Records.
  Batch Release and QC records.

Performance Evaluation assessment and remediation
  Co-ordinate with NRTL/Accredited test lab for Safety, Regulatory Compliance

Technical File preparation
  Dossier/Technical fle preparation according to accepted TOC.
  CE- Marking ownership.
  Support during onsite audit by the regulatory agencies or Notifed Body

Post Approval Support (Design for Compliance)
  Maintain Dossier/Technical Files
  Track Standards & Regulations
  Change Impact Assessment
  Post-Market Incidence/event reporting.
  Complaint handling
  CAPA tracking and Tech File update