Validated Clinical Device

A Validated Clinical Device is an clinical device/medical device that has been approved by regulatory authority as valed therapeutic treatment .

• AKA: Approved Medical Device.
• Example(s):
  • a Validated Pulse Oximeter.
  • ...
  • …
• Counter-Example(s):
  • a Home-based Medical Device.
  • a Validated Arterial Oxygen Saturation Clinical Device (SaO2), as determined by an arterial blood gas test.
  • …
• See: Medical Device Development Clinical Trial, Wearable Medical Device, Remote Patient Monitoring (RPM) System, Investigational Device Exemption (IDE) Program, Early Feasibility Studies (EFS) Program.

---

---

References

2021

• (Ghosh et al., 2021) ⇒ Sumanta Ghosh, Dipesh Shah, Namdev More, Mounika Choppadandi, Deepak Ranglani, and Govinda Kapusetti. (2021). “Clinical Validation of the Medical Devices: A General Prospective.” In: BioSensing, Theranostics, and Medical Devices, pp. 265-297 . Springer, Singapore,
  • ABSTRACT: Over the years, the spectrum of medical devices has been diversified from very simple to the highly complex platform, simultaneously the risk factor associated with the devices also diverges. So, now to be in no doubt and maintain the performance feasibility and clinical safety issues of any devices throughout the product life cycle, various regulatory organizations of different countries put some clause in the name of “clinical validation,” “clinical investigation,” or “clinical assessment report.” This clinical validation process makes convinced and justifies all the clinical assessment data regarding the devices’ safety, effectiveness, and performance feasibility to the regulatory agency to market the product in the specific market across the globe. The clinical validation procedure and requirement are very much specialized and succinct to answer all the queries of the regulatory body depending upon the device class, working principle, and risk associated with it. In recent times, various established regulatory frameworks like USFDA, TGA, and CDSCO make the clinical investigation and validation of the devices mandatory to launch the product into the respective market. The process of clinical confirmatory and validation is a never-ending procedure for high risk associated devices, as per the recent implementation of post marketing clinical follow-up (PMCF), post-market surveillance (PMS), and periodic safety update report (PSUR) by the regulatory authorities of various countries. In the following chapter, we are tried to give a broad impression and a detailed account of prerequisites, procedures, and strategies of various clinical validation plans concerning various regulatory authorities. The goal or intention of the clinical validation process of medical devices is to make assured that the device does not exhibit any surplus effect or events throughout its life cycle, which are questionable or reasons for product fiasco.

---