Our Services

Regulatory Affairs

  • Regulatory submissions (Health Canada, FDA, MDSAP, EU)

  • Global market registration and regulatory strategy

  • Notified Body and MDR support

  • Clinical evaluations, literature reviews, and post-market surveillance

Quality Management Systems (QMS)

  • QMS development, implementation, and maintenance

  • ISO 13485, ISO 9001, ISO 14971 compliance

  • Integration of regulatory and quality requirements

  • ESG gap assessments and integration into existing systems

Product & Process Support

  • New product development support

  • Design engineering and process validation

  • Technical file compilation, review, remediation, and maintenance

Audits & Compliance

  • Internal and external audit preparation and support

  • Audit training and readiness assessments

  • Supplier quality management and process improvement

Risk & Continuous Improvement

  • Risk management and risk-based approaches (FMEA, ISO 14971)

  • CAPA management and root cause analysis

  • Process improvement and quality tools implementation

Training

  • Customized training on quality and regulatory requirements

  • Practical, role-based training for teams and leadership