QMS ISO 13485 Medical Diagnostics Masterclass

The QMS ISO13485 Medical Diagnostics Masterclass was held on 29th February 2020 at the Chandaria Business Innovation and Incubation Centre at Kenyatta University.

The Masterclass brought together ecosystem builders, biomedical engineers, and hardware innovators to give an overview of the Medical Device Quality Management System, take participants through the Medical Device Product Development and shed more light on the Design Control Process.

The session was facilitated by Dr. June Madete, Biomedical Engineer at Kenyatta University & ABEC and Dr. Kenneth Chelule, CTO Medical Device Regulations at Greyhound Consulting.

To understand what innovators should look out for during their design process, Dr. June Madete took participants through Risk Analysis and explained the process of comparing estimated risk against given risk criteria to determine the acceptability of the risk.

She also highlighted it is the full responsibility of the manufacturer to ensure their product is compliant to regulatory requirements.

Dr. Chelule emphasized on the need for innovators to document every stage or iteration made during the innovation journey as this will make the process of regulatory approvals easier.

Key takeaways from the Masterclass were Innovators need to develop a product that

  1. The market wants and will pay for
  2. Will make a material difference in patient outcomes
  3. Is safe and reliable
  4. Can get regulatory approval
  5. Can be manufactured at a reasonable cost
  6. Can get IP approval.