Our team has installed numerous plants to manufacture medical devices for hemodialysis treatment (in particular dialyzers, but also blood lines, fistula needles, concentrate solutions, etc) and can support you with a 360° approach, from preliminary project analysis to successful product commercialization.

 

Our strengths include:

 

PLANNING

We can assist with planning a project from the early stages, including the realization of feasibility studies, space arrangements and factory layouts, identification of suppliers, commercial strategy and financial forecast.

 

TECHNOLOGICAL VERSATILITY

While we only offer high quality machinery, we can adapt the degree of automation and output depending on project needs, from primarily manual to fully mechanized solutions.

 

FINANCIAL PRAGMATISM

The ultimate goal of an industrial project is to generate a strong return on investment. As such, we focus on favoring financially effective solutions over unproductive sophistications, without compromising on the quality and efficiency of the production line.

 

TURNKEY PROJECT MANAGEMENT

In addition to installing production machinery, we are able to design, supply and set-up all necessary equipment to support production, including:

• Clean rooms and related air handling system

• Auxiliary equipment, such as water treatment plant, air compressors, electric panels, etc

• All electric, hydraulic and air distribution systems and connections

• Injection machines and molds

• Sterilization systems

• Laboratory equipment

 

ON-SITE INSTALLATION, START-UP

& TECHNICAL ASSISTANCE

The machinery we supply is installed and initialized under our responsibility and management. The set-up of a complete manufacturing line usually requires the onsite presence of 30+ engineers and technicians rotating for a period of 3 to 6 months, to perform commissioning, start-up and training. Furthermore, our team continues to provide technical assistance beyond the initial phase, according to the needs and arrangements of each project.

 

KNOWLEDGE TRANSFER

From the design of each product component to the configurations of each machine, from the specifications of each raw material to the parameters to be applied under each production step, we offer the necessary support to manufacture high quality products at an industrial scale. Specifically, each project includes a complete know-how transfer and training program, so that local management and staff can then autonomously run production, maintenance and quality control according to superior standards.

 

RAW MATERIAL PROCUREMENT

DiaSuisse Technology can supply all raw materials necessary for production and/or introduce the relevant suppliers.

 

QUALITY & REGULATORY SUPPORT

Our team can provide guidance on quality and regulatory requirements, from the realization of technical files, quality manuals, SOPs, equipment validations, required tests for product validation, etc. In particular, we have significant experience with CE marking and ISO 13485 certification in relation to medical devices.

 

We are at your disposal for a preliminary discussion on your project goals and requirements.