Our commitment to quality as a medical device distributor
1. Our commitment
Vitalex is committed to supplying safe, compliant, high-quality single-use surgical procedure packs, draping sets and gowns, and to meeting the needs of our customers and the patients they treat. Quality and patient safety are central to how we operate.
2. How we deliver quality
2.1 Supplier qualification
We work only with manufacturers that operate certified quality-management systems, including ISO 13485, and that can evidence the regulatory status of their products. Supplier selection and ongoing management include documented due diligence, and our Terms and Conditions of Purchase give the resulting expectations contractual force, including audit rights and change-control obligations.
2.2 Regulatory verification
Before a product is offered we verify that:
- ▪ it carries the correct CE or UKCA marking, or has lawful transitional status, for the market in which it will be supplied;
- ▪ the manufacturer is appropriately registered, and where the manufacturer is outside the UK, that a UK Responsible Person is appointed and identified;
- ▪ the device, system or procedure pack is registered with the MHRA before it is placed on the Great Britain market; and
- ▪ it is supplied with the required labelling, unique device identifier and instructions for use.
We record our own role for each product and supply arrangement (distributor, importer, or otherwise) and we confirm it to customers on request. Different rules apply in Great Britain and in Northern Ireland, and we do not assume that a position established for one market holds for the other.
2.3 Traceability
We maintain records that allow products to be traced by lot and batch through to the customer, so that we can support any recall or field safety corrective action quickly and accurately. Traceability is not an administrative task for us; it is the thing that determines how fast a defective lot can be pulled out of a theatre.
2.4 Storage, handling and distribution
Where we handle or store goods we do so in a way that preserves the sterile barrier and observes the manufacturer’s storage conditions and expiry controls.
Where distributor labelling is applied, it is supplementary only. It never obscures the manufacturer’s information, the unique device identifier, the CE or UKCA mark, or any standard symbol, and it is never placed across the sterile heat-seal border.
2.5 Complaints and vigilance
We record and investigate product complaints and manage adverse-incident information in line with our Medical Device Vigilance and Complaints Policy. Customers can report a product concern to customerservices@vitalexltd.co.uk marked “Product Quality Concern”, or by telephone on 0330 133 7551. We acknowledge product-safety concerns within one working day.
3. Our responsibilities as a distributor
We verify conformity before supply, maintain traceability, store and transport devices appropriately, cooperate with manufacturers and the regulator, and forward complaints and incident information without undue delay. We build these into our processes and we are able to evidence them.
4. Objectives and review
We set quality objectives, monitor performance, and review this policy and our quality arrangements at least annually. The Board is responsible for quality. Every member of the team is responsible for working to these standards.