Quality & compliance
What we require from manufacturers, and where our registrations stand.
We state our status plainly. Where something is in progress, it says so here.
Supplier requirements
| Category | Minimum we ask for | Also checked |
|---|---|---|
| Orthopaedic implants & instruments | ISO 13485 | CE marking or other approvals held; material certificates (SS 316L / Ti) |
| Lab & diagnostic equipment | ISO 13485 | Reagent availability, service and spares support |
| Medical equipment | ISO 13485 | Electrical safety documentation, user manuals, warranty |
| Nutraceuticals | WHO-GMP | Certificate of analysis per batch, shelf life, labelling |
| Consumables | ISO 13485 | Sterilisation method and validation where sterile |
These are requirements we apply to manufacturers. They are not certifications held by Scudder Healthcare. Copies of manufacturer certificates are shared with each quotation.
Registration status
| Market | Regulator | Scudder status |
|---|---|---|
| KE Kenya | Pharmacy and Poisons Board (PPB) | Registration in progress |
| TZ Tanzania | Tanzania Medicines and Medical Devices Authority (TMDA) | Registration in progress |
Company certifications: [PLACEHOLDER: add only once issued, e.g. IEC, ISO 9001]