Medical Engineering Services
Delivering equipment and technology without regards to the applicable norms in the country or countries where the products are destined to is not of great use.
Suisse Med Technologies pays a special attention to the marketability of the products produced by its customers.
ISO 9001 Quality management System is a must today that will command respect and diffusion world wide.
ISO 10993 is essential for the biological medical security to ensure that no harm can attain the users of the products
ISO 140001 Environmental Quality Management is an obligation for companies operating in the wide world of ecosystem.
ISO 13485 specifies a quality management system requirements that demonstrate a company’s ability to provide medical devices and related services that consistently meet the legal requirements applicable to medical devices and related services in terms of customer needs.
ISO 60601 Medical electrical equipment norms are essential to establish the security of the devices as far as electrical circuits is concerned
MDD 93/42/EEC This is the European path to get approval for use in Europe. Other norms are available for air filtration in clean rooms or water filtration in water. The list is long, but we will reproduce products that are compliant to all these norms.
FDA This is the USA path to get approval for use in the USA
Financial engineering services
SwissMed Technologies offer extensive engineering services, enabling you to increase production in a very short time frame. In combination with our manufacturing systems, we can also provide the design, installation, and upgrade of dialysis filter production plants.
Supply of qualified raw materials
We can supply a range of qualified raw materials, including:
We deliver everything required for the manufacturing processes. This covers Clean room ventilation equipment, reverse osmosis for the purification of water, chillers, oil-free dry compressed air, vacuum installations and solvent tanks and reservoirs.
We have contracted several reputable architectural engineering establishments in Switzerland and elsewhere to provide guidelines for the construction of plants compliant to ISO9001 and ISO 14000. Though aesthetics are important, the focus is on economic and long-lasting construction.
Our clean rooms are designed in several classes: S7, S8 and S9 (ISO 14644) according to the needs of the process. Some parts, according to ISO 9 are made based on European construction requirements and style. Overseas clients can customise the spaces according to your needs.
We also offer a range of miscellaneous services, including: