AllRound Technology has a particular success in Medical Electronics with extensive experience in designing and manufacturing of products at exceptionally high standards. We deliver services in each of the medical device product development areas to help your project reach the next milestone.
We act as a dedicated project partner capable of adding increasing value through every stage of the journey to market:
- Requirement definition & architectural design
- Product prototyping & initial testing
- Engineering & design
Certification of Medical Devices
Declaring a product as a medical device has a significant, scientific, engineering and business impact. AllRound technology has an extensive experience in certifying medical devices according to the stringent European standards that are acknowledged globally.
Medical Device Classes
Medical devices are classified into one of four classes: I, IIa, IIb and III. This classification is based on the specific devices’ invasiveness, duration of continuous contact with the body, the nature of the tissue contact and whether the device is non-active or active.
Medical Devices are in general divided into:
- Class I – includes devices with low risk, such as external patient support products
- Class IIa/b – covers devices with medium risk, such as electro-medical devices
- Class III – comprises devices with high risk, such as cardiovascular catheters
Help design and manufacture your products
We help our customers in:
- Designing and manufacturing of products at exceptionally high standards
- Develop a consistent and effective quality management system, technical documentation, essential product requirements
- Marketing according to harmonized methods
- Information about standards, regulations, risk analysis and a retention system for certain critical documentation
This by managing the risks and balancing the cost versus risks aspects to minimize the cost of the development.
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Medical Electronics & Certification
AllRound Technology has been succesful in designing and manufacturing medical electronic products and has an extensive experience in certifying medical devices.Read More