Medical Device Service

Medical Device Service

Medical devices play a crucial role in modern healthcare by aiding in the diagnosis, treatment, and monitoring of various medical conditions. Ensuring the safety, efficacy, and quality of these devices is paramount to protecting patient well-being. This is where Protheragen-ING Lab's medical device services come into play.

We specialize in providing comprehensive medical device services to help you bring safe and effective healthcare solutions to the market. Our team has extensive knowledge and experience in the medical device industry, ensuring that your devices meet regulatory standards and undergo rigorous testing and validation processes.

Fig.1 Medical Device Service

We Know Medical Devices

Medical devices range from simple tools such as thermometers and blood pressure monitors to complex devices such as pacemakers, imaging systems and robotic surgical systems. They can be categorized into different classes based on their intended use and potential risks.

Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and regulations to ensure the safety, effectiveness, and quality of medical devices.

Protheragen-ING Lab is supporting medical device companies around the world. We understand the principles of medical devices and their regulatory requirements. Most importantly, we know how to apply risk analysis to your products and apply the results to provide fast, cost-effective design validation and verification services.

You will benefit from this inside knowledge, gained through extensive testing experience with all classes of devices and many applications.

Find out more about each of our services

Protheragen-ING Lab offers a range of medical device services to support your product development journey. We work closely with you to understand your unique needs and provide customized solutions to meet them.

This service involves a series of rigorous evaluations to ensure that medical devices meet strict safety standards. One important aspect is bacterial endotoxin testing (BET), which evaluates the presence and concentration of endotoxins in medical devices, especially those that come into contact with blood or other sterile areas.

Fig.2 Design validation and process verification for medical devices.

Contact us today to discuss how our services can support your specific requirements and contribute to your success in the pharmaceutical market.