Software Validations

Makromed, Inc. has extensive years of experience developing and validating software in the medical device, diagnostic, pharmaceutical, nutraceutical, and biotechnology industries. Your company needs to be on top of new technology trends to provide secure and safe software to customers which meets regulations from such agencies as FDA, EU, and Health Canada.

We will be happy to be part of your improvement, offering the following services:

  • Assess current Software Validation policies to identify gaps according to FDA- 21 CFR Part 11, ISO 13485, ISO 14971, AAMI TIR57, GAMP 5, and more
  • Establish procedures and policies for managing Software Development Life Cycle (SDLC)
  • Establish procedures on how to validate Software as a Medical Device:
  • Quality Plan
  • Classification
  • Cybersecurity
  • Software BOM or list of SOUPs
  • Risk Analysis (Level of Concern)
  • SRS
  • Software Testing
  • Establish procedures on how to validate COTS Embedded Manufacturing Equipment and QMS Software:
  • Risk-based approach
  • 21 CFR Part 11 considerations
  • User Requirements
  • Software Testing
  • Training in all relevant topics of Software Validation