Maziwa

Wema is the only breast pump specifically designed for working mothers in developing markets. 87% of women who have tried the Wema breast pump in our research preferred it over other commercially available pumps.

What we delivered:

  • Market / Product Requirements Specifications (Design Inputs)

  • Risk Management Plan

  • Preliminary Usability Evaluation

  • Preliminary Hazard Analysis

  • Quality Plan

  • Quality Management System Procedures

  • Packaging and Labeling Design

  • Product Photography

  • Design Verification

  • Kenyan Regulatory Submission

  • 3rd Party Manufacturer Engagement

Breast pump product concept illustration
Breast pump medical device packaging design
Medical device instructions for use example

The Ontogen team was indispensable in leading the launch of our Gen 1 breast pump in Kenya. They finalized the product, established overseas supplier relationships, developed our QMS and DHF, and submitted to the Kenyan regulatory authorities on-time and under budget. They truly feel like an integral part of my team and are always providing strategies with Maziwa’s best interests in mind.

- Sahar Jamal, Maziwa Breast Pump (Entrepreneur, Founder & CEO)

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