AllRound Technology has had 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 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 by:
- Designing and manufacturing products of exceptionally high standards
- Developing a consistent and effective quality management system, technical documentation, and essential product requirements
- Implementing marketing according to harmonized methods
- Informing them about standards, regulations, risk analysis, and by creating a retention system for specific critical documentation
We help our customers manage the risks and balance them against the cost versus risk aspects, this minimizes the cost of development and ensures the best possible solution for them.
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Medical Electronics & Certification
AllRound Technology has been successful in designing and manufacturing medical electronic products and has extensive experience in certifying medical devices.Read More
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