Biomedical Systems Integration

Professional biomedical software consulting for US FDA and Health Canada product development and regulatory approval submissions.

Biochemical analyzer laboratory equipment with computer workstation

Laboratory Systems & Automation

Burke Consulting provides software consulting for laboratory automation and immunoassay analysis systems. Our experience with regulated laboratory environments enables us to deliver solutions that meet the stringent requirements of clinical and research settings, from instrument integration and data acquisition to automated workflow management and results reporting.

Regulated Software Development

Burke Consulting provides Biomedical Software consulting services for US FDA and Health Canada product development and approval submissions. Our expertise ensures your medical device software meets the highest regulatory standards throughout the entire product lifecycle, from design controls and risk management to verification, validation and post-market surveillance.

Biomedical Consulting Services

  • ISO:13485 Compliance
  • Risk Based Designs
  • Policy and Procedure Development
  • Automation and Software Analysis for Immunoassays