Quality management system
A medical device distributor does not sell boxes. It safeguards a chain of responsibility.
From the time a unit leaves the manufacturer until it reaches your practice, someone must ensure that it remains while remaining the same product, stored as specified by the manufacturer and traceable by its batch. That party is us we do. This page explains how: what the regulations require of a distributor and which procedures we apply to every order.
The framework: what the law requires of a distributor
Regulation (EU) 2017/745 (MDR) and Royal Decree 192/2023 precisely define what anyone who distributes medical devices. This is not a recommendation: it is an obligation that can be verified by the competent health authority medical devices. Our quality system is built on these obligations.
Verification before placing on the market
Verify that each product bears the CE marking, has an EU declaration of conformity, labeling and instructions in the required language, and, where applicable, a unique device identifier (UDI).
Storing as specified by the manufacturer
Store and transport products under the temperature and humidity conditions specified in each technical data sheet, with records demonstrating compliance.
Ensuring traceability
Be able to identify at any time to whom each batch was supplied and from whom it was received, throughout the entire legally required record-retention period.
Responding to incidents
Notify the manufacturer and the competent authority of any suspected non-conforming product or incident, and participate in any field actions or recalls ordered.
Our procedure, order by order
This is how Alpha Iberian’s quality and warehouse team works with every product movement:
- 1Supplier qualificationWe purchase only from the manufacturer or its authorized distributor for Spain. Before the first order, we document the supply chain and archive the supplier’s accreditation.
- 2Receipt and incoming verificationEach delivery is checked against the order: reference, quantity, batch, expiry date, packaging integrity, correct-language labeling, and seal condition. The manufacturer’s conformity documentation is verified.
- 3Quarantine and releaseThe goods remain blocked until incoming verification is complete. Only a verified and registered product is released to saleable stock.
- 4Controlled storageOur own warehouse in Madrid with temperature and humidity control and continuous monitoring. Products requiring refrigeration are stored in dedicated equipment with temperature monitoring.
- 5Batch management (FEFO)The batch with the nearest expiry date is served first. No product is dispatched with an expiry date that does not meet our minimum service-life margin.
- 6Preparation and dispatchBatch-based picking, double-checking against the order, protective packaging and, when required by the product, temperature-controlled transport. The delivery note records the batch number and expiry date of each unit.
- 7Post-sale traceabilityEach batch is linked to the customer who received it. In the event of a communication from the manufacturer or health authority, we locate and inform them within hours, not days.
What we guarantee in writing
- OriginOfficial documented channel for every catalog reference. No opportunistic purchasing or parallel-market products.
- ConformityCE marking and manufacturer documentation available for every medical device we distribute.
- StorageWarehouse and shipment temperature and humidity records for consignments requiring cold-chain conditions, available upon request.
- TraceabilityBatch number and expiry date on every delivery note and in our distribution record, retained for the legally required period.
- VigilanceIncident communication and product recall procedure coordinated with the manufacturer and the competent authority.
Continuous improvement
We record every nonconformity — a unit with damaged packaging, a transport delay, an error in picking — and we analyze its cause. The aim is not only to correct the case but also to prevent it from happening again. Our Quality indicators are reviewed monthly by Alpha Iberian management.
PIEL ETERNA acts as a distributor. Responsibility for the design, manufacture, and conformity of the the product belongs to the manufacturer; our responsibility is to ensure that the product reaches your practice exactly as it left from the factory. If you have any questions about a batch, we will help you raise them with the manufacturer.
Do you need documentation for a batch?
Write to us with the reference and batch number. We will send you the origin and storage records for that unit.
info@pieleterna.es WhatsApp +34 610 42 61 46 · Mon–Fri 09:00–17:00
Alpha Iberian Soluciones Médicas SL · Tax ID B19405521 · Registered office: Calle de Hermosilla 48, 1st floor, 28001 Madrid · Distribution license 07-1409-00167.4/2024 (Community of Madrid) · Sale exclusively to healthcare professionals.