Performance at all levels
seleon specialises in the production of complex, sophisticated and standards-compliant devices. We have the experience, the infrastructure and the quality management processes required to manufacture high-quality medical devices.
Whether it be a custom production run of small, medium, zero or first series, prototypes or special systems, the assembly of ready-to-sell products or global shipping to the end customer, with seleon, you are choosing a partner that adjusts perfectly to your needs at every level.
Production
Thanks to flexible production capacities, we can manufacture your product in a short space of time with the standard of quality you require and in accordance with the joint quality assurance agreement. Our certified processes, together with the observance of Good Manufacturing Practice (GMP) guidelines, ensure that your product is manufactured in accordance with all the relevant standards and requirements.
On request we will produce detailed production and testing instructions, a complete Device History Record (DHR) and product-specific production and test equipment to assist with production. Our experts can also provide support with change management, technical service and ongoing maintenance of your product.
Batch Production
If you have very specific requirements, you can rely on the expertise of an experienced, dedicated production team who will turn your one-off concept into reality even without a defined production programme.
Zero Series
The transition from development to actual series production is often fraught with problems. So it makes sense to involve the developer, who is already very familiar with the product. With seleon you can be confident that the first series of your new product will be delivered efficiently and reliably.
Small Series
In today’s globalised marketplace it’s increasingly important to launch products on to the market quickly. This requires smaller series that are produced to tighter schedules. Even if you intend to market your product with several different variants, each in a small quantity, we have the expertise you need. We can manufacture even small batches of complex devices cost-effectively and to a high quality standard. And because our production and logistics processes are organised on a project-oriented basis, we also have the flexibility to implement changes at short notice.
Series
The transition to a large production run presents a number of challenges. Components have to be sourced more cheaply, production processes have to be optimised and every possible saving must be exploited in packaging and delivery. Our experience in series production gives you the necessary peace of mind.
Special systems
Our highly qualified team can also produce special systems and individual design samples.
Production and test equipment
Whether your products are being manufactured by us or another company, we can develop and produce the necessary production and test equipment. You benefit from the know-how of our production automation experts.
Quality management
Quality management in the production process
We apply quality management throughout every stage of production. You decide what scope of documentation is required and we provide the necessary documents for traceability purposes. This process includes:
- Production of test concepts and test documents
- Verification and management of production documentation
- Ensuring traceability up to the individual user
- Carrying out checks during production phase
- Supervising product maintenance
