Security
Patient safety, reliable supply and protection of your data are our highest priorities.
Products
SANOVIO Fulfillment is a modular service. Depending on your requirements, we take on the role of importer or distributor under the MDR, or only individual steps of the process.
Our quality team qualifies every manufacturer before listing and carries out on-site audits based on a risk assessment.
Every batch undergoes a goods-in inspection before we store and deliver it.
Data
Your data is stored on servers in the EU and encrypted in transit and at rest.
Neither we nor our model providers use your data to train AI models.
We process your data under the GDPR and on the basis of a data processing agreement.
Standards
Product path
We offer these steps as a service, individually or as a whole, depending on which parts of the process you hand over to us.
Before listing, we review certificates, the declaration of conformity and registration. On-site audits are risk-based.
CE marking, labelling, instructions for use and UDI are checked against the requirements.
For every batch we check the UDI, batch number, expiry date and condition of the goods.
Goods are stored in our own warehouses in Germany or a partner warehouse in Switzerland, under the manufacturer’s conditions.
The batch number is documented through to delivery at your facility.
Importer and distributor
SANOVIO Fulfillment is modular. Which regulatory role we take on depends on your requirements. If we place devices from a manufacturer outside the EU on the market, we act as importer under Art. 13 MDR. If we pass on devices from an EU manufacturer, we act as distributor under Art. 14 MDR. If we take on individual steps only, we meet the obligations that apply to that part. The infrastructure for all of this is in place.
We check the CE marking, declaration of conformity, labelling and UDI before a device is made available.
For imported devices, we state our name and address on the device, its packaging or an accompanying document.
We are registered as an importer in EUDAMED and swissdamed.
We record complaints, non-conforming devices and recalls, and forward complaints to the manufacturer.
Storage and transport are carried out so that devices remain compliant.
If we suspect non-conformity, we inform the manufacturer, and in the case of a serious risk also the competent authority.
Questions
SANOVIO’s quality team. It qualifies every manufacturer before listing and inspects every batch at goods-in. On-site audits are based on a risk assessment, in which an established European manufacturer is assessed differently from a contract manufacturer outside the EU.
All medical devices in our range may lawfully be placed on the market. This includes devices that meet the MDR as well as legacy devices with a valid certificate under the former directive, which may still be placed on the market under the transitional provisions of Art. 120 MDR. Items that are not medical devices are checked against the regulations that apply to them.
No. We agree the role we take on together with you, because SANOVIO Fulfillment is a service you use modularly. If we place a device from a manufacturer outside the EU on the market, we are the importer under Art. 13 MDR. If we pass on a device from an EU manufacturer, we are the distributor under Art. 14 MDR. If we take on individual steps only, such as goods-in inspection or storage, the regulatory role stays with the respective economic operator, and we meet the obligations that apply to our part. On request we handle the entire process, as the infrastructure for it is in place.
In our own warehouses in Germany or in a partner warehouse in Switzerland. If your facility has its own storage, we also deliver directly. Every delivery can be tracked until it arrives.
We implement the manufacturer’s measures and quarantine affected batches in the warehouse. As the batch number is documented through to delivery, we can identify affected facilities precisely and inform them directly.
Data
Your data is stored on servers in the European Union.
Data is encrypted in transit and at rest.
Neither we nor our model providers use your data to train AI models.
Role-based access rights and separate data rooms ensure that only authorised users in your organisation have access. Logs make actions traceable.
Our cooperation is based on a data processing agreement under Art. 28 GDPR.
Our security controls are monitored continuously. An incident response plan defines how we handle security incidents.
Questions
On servers in the European Union. The data is encrypted in transit and at rest.
No. Neither we nor our model providers use your data to train AI models.
Only authorised users in your organisation. Role-based access rights and separate data rooms govern access, and internally a documented access policy applies as well.
Yes. We sign a data processing agreement with you under Art. 28 GDPR, which also specifies the sub-processors we use.
An incident response plan sets out the procedure step by step. If personal data is affected, we inform you without undue delay, as the GDPR requires.
Who it’s for
You source products from qualified manufacturers, inspected at goods-in and traceable through to delivery. Only the people you authorise have access to your data.
You pool demand for products of verified origin and conformity. We process your members’ data under the GDPR and on the basis of a data processing agreement.
We qualify you against defined, risk-based criteria. You maintain your product data in SANOVIO aOS, encrypted and hosted in the EU.