De Koningh Medical Systems concentrates on the manufacture of precision engineering, microtechnology and mechatronics exclusively for third parties. We design, manufacture, assemble and test. You determine which part of this process you want De Koningh Medical Systems to provide. We gladly leave the marketing of medical products to our customers. In brief, we are dedicated to transforming your opportunities in the medical market into a successful product.
We are active in five medical sectors:
- Diagnostics & Monitoring
- Surgery
- Rehabilitation
- Treatment & Therapy
- Laboratories
CLICK HERE – To know Why De Koningh Medical Systems?
Diagnostics & Monitoring
We manufacture equipment, measurement instruments and tools for diagnostics & monitoring that are used to establish or monitor the patient’s condition.
All products must be approved by the local authorities before they can be used for medical practices. This approval is acquired by having the equipment validated. This means that the equipment, measurement instruments and tools are checked against the set criteria as determined by the local authorities. To comply with the validation, the equipment must be manufactured according to a validated process by an ISO13485 certified company.
In the development of new products or preparing prototypes for manufacture in this industry, broad understanding and experience is often imperative in addition to the ISO 13485 certification. Through our wide experience and large network of universities, research agencies, suppliers and partners, we always have access to the necessary knowledge. We are also glad to take on the manufacture, assembly and final testing for you.
Surgery
We supply the surgical profession with all sorts of instruments for surgical operations that are not available as standard.
Instruments that are used for surgery must be able to be sterilised properly. Above all, they must be chemically inert, extremely well-finished, suitable for intensive use and able to withstand heavy loads. In addition, it is a requirement that these instruments are ergonomic and light to operate.
Besides an experienced design team, these often conflicting demands require considerable experience for the manufacture of these instruments. As well as contact with users to receive useful feedback. In addition to this knowledge and experience, disciplines such as aesthetics, ergonomics, user-friendliness, manufacturability, knowledge of materials and processes, knowledge of rules and regulations and of course medical knowledge are of importance. We do not just have a team of experienced engineers, but also a large network of universities, research agencies, suppliers and partners that have mastered one or more of the above-mentioned disciplines.
In the development of surgical instruments the prototype phase is very important. Through clinical tests we check if the design will work in practice. In this phase, the flexibility and creativity of both the design team and the prototype builders are of great importance. A prototype often has to be developed and altered inside a relatively short period of time. De Koningh Medical Systems has set up its organisation in such a way that it can act decisively in this process.
Rehabilitation
Rehabilitation focuses on the recovery or improvement of capabilities in people with a permanent physical injury or a functional limitation. There are millions of people worldwide with such a functional limitation, which can have far-reaching consequences in daily life. A small auxiliary aid or supporting system can often make a big difference to a patient’s life.
In 2004, the rehabilitation sector provided care for 38,500 outpatients, including more than 7,700 children and young people and 7,400 clinical patients, including 400 children and young people. The last few years have seen a sharp growth in rehabilitation, which has continued in 2006. The number of hours of rehabilitation treatment increased by 8%. In the Netherlands, approximately 8,000 people work in the rehabilitation sector. The budget available in 2006 was more than €400 million.
Much of the equipment and many of the instruments and auxiliary aids employed in rehabilitation utilise external stimuli. Because of this, the requirements made of this equipment are often less rigorous than for those in direct contact with internal organs. In the majority of cases, CE certification is sufficient for using the product concerned. De Koningh Medical Systems is the ideal partner for making and testing the prototype of this developed product or system. So that customers can market the product themselves. ISO 13485 is not essential in this industry, but it does indicate De Koningh’s level of quality. Many rehabilitation products are assembled in low-dust environments.
Treatment & Therapy
This includes all equipment, instruments and auxiliary aids that are used for treatment and therapy for patients to stimulate recovery from illness. This can be extremely advanced equipment for treating serious illness. But also more general equipment, used by dentists or physiotherapists.
High sterilisation demands are made of instruments that are used for treatment and therapies. They must be good and easy to operate, but also ergonomically easy to handle. To comply with the validation, the equipment must be manufactured according to a validated process by an ISO13485 certified company.
De Koningh Medical Systems has a team of experienced engineers, who can, together with you, turn a good market or product idea into a successful instrument or system. De Koningh can act as a project manager. Once the design, prototype and validation process have been concluded, the equipment, measurement instruments and/or auxiliary aids have to be manufactured. We can do this too! In addition to an extensive manufacturing facility for precision engineering, De Koningh Medical Systems has its own assembly team that has a clean room facility of class 1000 and 10000 at its disposal.
Laboratories
Medical research focuses mainly on human health. This is chiefly performed in laboratories. Examples are the pharmaceutical industry, TNO Prevention and Health, National Institute of Public Health and the academic hospitals and universities. Public health is an increasingly important issue in Dutch society. This is illustrated by the annually growing number of companies and research institutes.
We build instruments and systems for various customers that are used in medical laboratories. In addition, we are actively involved with other laboratories, such as the food industry and the glass industry.
Over the last few years, De Koningh Medical Systems has exhibited at the specific laboratory trade fair Het Instrument. We are looking for customers who sell laboratory systems to the market, but leave the design, manufacture or assembly to a third party. We take this concern off their hands, so that our customers only have to concentrate on what they excel in: development and sales.
