Implantable Medical Device or tissues are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues. Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other materials.
Implantable Medical Device can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed. Medical implants are products that have to satisfy functionality demands defined by the working environment-human body.
Implantable medical devices need mandatory CDSCO registration as per MDR2017.Regulatory authority has issued checklist of document which are needed at the time of registration, to create a file of these documents and to get the manufacturing license easily you can contact our team.
The risks of Implantable Medical Device include surgical risks during placement or removal, infection, and implant failure. Some people also have reactions to the materials used in implants. All surgical procedures have risks. These include bruising at the surgical site, pain, swelling and redness. When your implant is inserted or removed, you should expect these types of complications.
Development of Implantable Medical Device is an emerging field. With the influx of MEMS technology into implantable devices, a niche area of work has been identified. Since most of the research work is currently being done in research labs, a good source for further information would be peer-reviewed journal articles.
- Implantable Medical Device
The implantable technology is making today’s medicinal drugs even more participatory, predictive, and personalized. These devices use IoT (Internet of Things) concepts to continuously monitor human health parameters and securely report any anomalies to physicians.
Active implantable medical devices are powered devices that are inserted into a patient’s body, through either a natural orifice or by surgical means, and are intended to remain in the patient’s body after the procedure. Such devices are usually battery powered, and the power supply can either be contained in the instrument or be connected to wires that protrude from the patient’s body.
Examples of Active Implantable Medical Devices
An example of an active implantable medical device is the internal, long-term blood pressure sensor Proven Process was the first company to develop such a device. This tubular appliance was designed to monitor blood pressure via an electrical resistance strain-gauge sensor.
One of the biggest challenges with such a device is measuring the flow of blood without significantly constricting or altering the hemodynamics. Another example is the implantable ventricular assist device a vascular pump that helps weakened heart muscles provide sufficient blood flow. Proven Process sought to improve on existing ventricular assist devices.
Implantable Medical Device Manufacturing (Design and Manufacture)
The design and manufacture of active Implantable Medical Device require special considerations beyond those associated with other medical implements. The operating parameters of such devices must be specified to precise tolerances to prevent unintended harm to the patient.
An example of such a parameter would be the temperature of the device. Although the device may function quite well in a wide range of temperatures, standards require the device to operate no more than 2℃ above normal body temperature (37℃).With the exception of those parts intended to convey an electrical charge to the body, the exterior must be electrically neutral.
Implantable Medical Device are among the most complicated to manufacture. Their design must take into account multiple factors that do not affect other devices and, therefore, requires a highly specialized and experienced team. Because of their extended lifecycle and prolonged contact with patients, they are subject to the most stringent standards and regulations.
We have good team of medical device regulatory consultant who has better understanding of documentation needed for the registration of medical device and who can resolve all doubts related to the process.
