Quality Assurance & Regulatory Compliance
Quality is designed in, not inspected in.
Venora is building a quality management system (QMS) aligned with ISO 13485:2016, the international standard for medical device manufacturers. It covers design, purchasing, production, testing, storage, complaints and corrective action.
Regulatory
All products will be manufactured and sold only under the licences and product registrations issued by the Ethiopian Food and Drug Authority (EFDA).
No certification is claimed until a certificate is issued by an accredited body.
Where the table below says a standard is a design basis or is targeted, that is what it means: we design to it today and will seek certification once the plant is running.
Standards framework
The standards that shape our products and plant.
| Standard | Scope | Venora status |
|---|---|---|
| ISO 13485:2016 | Quality management system for medical devices | QMS in development; certification targeted |
| ISO 14971:2019 | Risk management for medical devices | Applied in product design |
| ISO 6710:2017 | Single-use venous blood specimen containers | Product design basis |
| ISO 14644-1 | Cleanroom air cleanliness classification | Facility design basis |
| ISO 11137 / 11135 | Validation of radiation / ethylene oxide sterilisation | For sterile products |
| ISO 15223-1 | Symbols for medical device labels | Labelling design basis |
| EFDA | Manufacturing site licence and product registration | Required before supply |
Quality control
Four checkpoints, from resin to the field.
- 01
Incoming
Resin, additives and packaging checked before use.
- 02
In-process
Dimensions, dosing and vacuum monitored on line.
- 03
Final release
Draw volume, leakage and labelling checked per batch.
- 04
Post-market
Complaint handling, recall readiness and CAPA.
Let’s build Ethiopia’s medical manufacturing future together.
We welcome enquiries from health institutions, distributors, investors, suppliers and development partners.