Our production - made to measure
We take care of the contract manufacturing of your medical device from prototype to series production - even if you have developed it elsewhere.
We take care of the contract manufacturing of your medical device from prototype to series production - even if you have developed it elsewhere.
Production transfer
Zero series
Series production
Quality assurance
Logistics
Lifecycle management
To ensure an optimal manufacturing process right from the start, we define the appropriate processes, technologies and materials to prepare our production for your product. This applies to projects developed in-house as well as to third-party developments and production takeovers. Early equipment management is our motto.
With the pilot or pilot series, we check whether the transfer from development to production is successful - and whether the devices can be produced in accordance with the production instructions drawn up. This is how we ensure that the development object is ready for series production.
In small series production, we can produce up to 10,000 medical devices per year. With our one-piece flow production islands, we work exclusively according to international standards and your requirements.
Each end product is assigned a unique serial number. This number is used to electronically document all production steps and material flows. This enables BYTEC to meet the traceability requirements of the MDR and FDA.
Our quality assurance accompanies the goods and products from goods receipt to the specified end product ready for delivery. We record incoming and outgoing goods inspections in the production documentation - quality "Made in Germany".
Complete systems, quality-tested, labeled and packed ready for dispatch: with our logistics partners, we meet your requirements in terms of delivery date, method and place of dispatch.
Thanks to internal control of purchasing, resources, storage and the monitoring of component discontinuations, we enable our customers to achieve optimum delivery capability and maximum delivery reliability - perfect supply chain management.
We manufacture medical devices for you on over 2500 square meters! In addition to our various production lines for workflow-optimized production, this also includes our semi-automatic high-bay warehouse. This gives us quick access to components and, if necessary, spare parts so that production can run smoothly and without interruptions.
We manufacture your products in high quality. We ensure this above all with our experienced and well-trained team, as well as a production process optimized by LEAN thinking.
Dennis Mallmann
BYTEC offers an end-to-end service portfolio:
· Design transfer to series production
· Material procurement and supply chain management
· Quality-assured production and testing
· Traceability in accordance with MDR and DIN EN ISO 13485
Our products are manufactured using a validated ERP system. This ensures that all parts used are fully recorded, including serial and batch numbers, at all times.
By inspecting all incoming goods and conducting regular supplier audits, we set high standards for the materials we store in-house. Our products are assembled exclusively by skilled production workers, primarily electronics technicians. We offer a highly flexible assembly line, which we constantly adapt and optimize to the requirements of the product in accordance with the 6S lean concept. This enables us to work economically and significantly minimize waste. All our products are thoroughly tested by our quality assurance department after production.
As an ISO 13485, MDR, and FDA-certified company, regular on-site audits are conducted. This allows us to verify that our products are manufactured safely, effectively, and in compliance with applicable regulations.
