Quality Management Systems (QMS) Documentation Workshop Report in Uganda

From April 22nd to April 26th, 2024, the Acacia Hotel in Mbarara, Uganda, hosted our Quality Management Systems (QMS) Documentation Workshop. This event, led by Eng. Wambui Nyabero, Winnie Wangari, and Stacy Awinja, aimed to support our Invention Based Enterprises (IBEs) by addressing challenges in documentation and design.

Topics Covered

Documentation and Design

The workshop placed significant emphasis on medical device documentation as guided by the ISO 13485 standard for Quality Management Systems for medical devices. Winnie Wangari led sessions to review existing documentation practices and introduced the ISO 13485 Documentation Canvas. Participants reorganized their documents using this new format, facilitating better management and compliance.

Pitch Development

Elevator pitch sessions were conducted to help participants effectively communicate their business ideas. Emmanuel Kamuhire, CEO of Alite, and other participants presented their pitches and received constructive feedback to enhance their delivery and content. We were also grateful to have Moses Ochora, CEO of Photokabada, and Nura Izath, CEO of Neosave Technology.

Market and Production Challenges

Discussions centered on addressing market challenges, particularly supply-chain issues. The workshop emphasized the need to involve manufacturers early in the design process to ensure product feasibility and quality. Engaging with government bodies was also highlighted as crucial for creating favorable policies for innovation.

Regulatory Insights

The workshop tackled regulatory challenges, focusing on collaboration with the National Drug Authority (NDA) to co-create necessary documentation for traceability. This approach aimed to streamline the approval process and ensure compliance with local regulations.

Site Visits and Design Feedback

Our team conducted multiple site visits to understand the technical challenges faced by the IBEs:

• Neosave Facility: Focused on the Autothermo device technology, providing recommendations for further improvement.
• Photokabada Team: Evaluated verification processes and suggested design adjustments. The team showed progress but had room to grow in terms of enhancing internal approval processes and technical expertise.
• A-lite Facility: Highlighted the importance of structured production processes and stringent quality checks.

Key Outcomes

• Participants adopted the ISO 13485 Documentation Canvas for better document organization and compliance.
• Recommendations for design improvements were made. 
• Advice given on enhancing internal approval processes and gaining technical expertise.
• Emphasis was placed on engaging manufacturers in the design process and collaborating with government bodies to address supply-chain issues and regulatory challenges.

The QMS Documentation Workshop in Uganda was a productive event focused on enhancing documentation and design processes for Villgro Africa's IBEs. The workshop provided valuable insights and actionable recommendations, setting a clear path for future improvements in the medical device industry.

We will continue to support these enterprises and monitor their progress, ensuring they implement the improvements discussed during the workshop. Stay updated for more insights and developments from Villgro Africa.

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