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Medical Engineering Services

At Swiss Med Technologies we provide a range of engineering services for our clients around the world. Please get in contact our teams to evaluate your needs and finding solutions.

Regulatory compliance

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.

  • Business and engineering services
  • Business plan
  • Plant design
  • Regulatory requirements
  • Quality system management

Supply of qualified raw materials

We can supply a range of qualified raw materials, including:

  • Medical grade chemicals
  • Polycarbonate
  • Polyethylene
  • Polypropylene
  • Polysulfone
  • Polyethersulfone
  • Polyvinylpyrrolidone
  • Polyvinylidene difluoride
  • Polyurethane

Engineering infrastructures

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.

Civil engineering

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.

Miscellaneous Services

We also offer a range of miscellaneous services, including:

Spare Parts

We recommend you locally stock a set of the most used parts that are subject to the most frequent wear and tear, as well as parts that are of critical importance to the manufacturing process. We can supply all the necessary spare parts.

Installation

We provide supervision of the installation and commissioning on-site and connection to utilities through the main power distribution panel, including all necessary protections. Note: This will require the participation of your own maintenance engineers.

Validation

Once the Assembly Line is in place, the process of re-validation is initiated using your components. The validation will be concluded when the output performance of the equipment reaches a satisfactory level. Note: This will require the participation of your maintenance engineers. Note 2: You must provide enough raw materials to validate the equipment.

Packing, Shipping & Insurance

Each piece of equipment will be loaded on a treated wood platform of the appropriate strength to carry the load. The complete shipment is then packed under retractable aluminium foil to inhibit any deterioration of the equipment during transportation. Shipping will be completed in containers, with loading by the supplier, while unloading from the ships will be the client’s responsibility.

Training

Your staff will be involved in the validation as part of their training. Additional training will continue for up to two weeks.