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Regulation is something where medical devices undergo a clinical investigation to sell in the market for human use. It is under the Directive 93/42/EEC which relates to testing medical devices.
The quality of a product is always crucial to buy it. Our team works hard to ensure your product’s quality is up to the mark. We promise to meet all the requirements as per the standards.
Clinical Evaluation is a procedure that involves grabbing and assessing all clinical data of medical devices/IVD works, and checking if there is efficient evidence required for the relevant regulations. Our foundation assists to evaluate your device and fulfill the requirements.
Software is one of the accessories of a medical device. Software validation and verification is important to check if the device is safe. Validation is done by creating a document as a piece of evidence that confirms that the device is installed and working correctly.
- Product Document
Developing a product document is not an easy task. One needs to do core research and development to create documents for medical devices. A Product Requirements Document (PRD) includes the purpose, functionality, features, and behavior of a medical device.
Remediation for medical devices is found and fixed by the Regulatory Compliance Associates (RCA). The associate helps to solve any complex regulatory challenges. RCA works worldwide and provides services in the fields like pharmaceutical, sterile compounds, biological & biotechnology, medical device, and lab testing.