Quality Assurance and Regulatory Affairs (QARA) play a vital role in the safe and successful delivery of healthcare products and services.

While smaller organisations often focus heavily on research and development, they can struggle to keep pace with the growing complexity of regulatory requirements. That’s where our dedicated QARA team makes the difference.

Expert Guidance Across the Product Lifecycle

Working closely with every department, the TOGL QARA team expertly navigates businesses through the evolving landscape of compliance—from initial concept through to final delivery. At the same time, we drive and embed a culture of quality management throughout the organisation, ensuring excellence at every stage.

Certifications & Compliance

Our team maintains and advances a robust framework of certifications and regulatory requirements, including:

  • ISO 13485 Quality Management Systems certification
  • CE Marking (EU MDR) and UKCA Marking (UK MDR)in line with the regulations
  • HTA (Human Tissue Authority) certification

Looking ahead, we are actively progressing towards:

  • IVDR (EU and UK) compliance
  • ISO 15189:2022 certification for our new commercial laboratories, opening in Cambridge in early 2026

Through this commitment, the QARA team ensures that TOGL companies and collaborators can deliver safe, effective, and fully compliant products to patients and healthcare systems worldwide.