We have classified the device as a Class II medical device. In accordance with FDA regulations, a Premarket Notification (510(k)) submission is required for Class II devices. We have determined that our device is substantially equivalent to a legally marketed predicate device. This determination involved a comprehensive analysis of existing products, identifying both similarities and differences between them and our device.
We are in full compliance with the FDA's Quality System Regulation (QSR), which encompasses requirements for design controls, focusing on user safety, production, and process controls. We have adhered to rigorous documentation practices from the outset to ensure comprehensive record-keeping.
Purpose: Design controls are implemented to ensure the device is designed to meet user requirements and regulatory standards while mitigating risks.
- Design and Development Planning: We have completed three prototype iterations: a demonstration prototype, an alpha prototype, and a limited batch production run of 15 devices. Each prototype underwent three test cycles, leading to iterative improvements in quality.
-
Design Input: The design was primarily developed to meet UNICEF's height measurement requirements for children, targeting a precision of approximately 1mm. Initially, the device exhibited a precision of 3cm, and we are working towards further refinement to meet these precision standards.
-
Design Output: Documentation demonstrates that the design meets user requirements and regulatory criteria. We have documented improvements through three test cycles and various prototype stages.
-
Design Verification and Validation: We ensure that the design meets all specified requirements through rigorous testing and evaluation. Achieving a precision of 3cm represents significant progress given the device's initial specifications.
-
Process Validation: The product enclosure has been optimized to maintain consistent printing quality.
-
Control of Production and Process Changes: We have selected reputable production partners and documented the selection process accordingly.
-
Production Records: We place significant emphasis on maintaining detailed production records.
-
Labeling: The device adheres to appropriate labeling requirements, including user instructions, indications for use, and necessary warnings or precautions.
Purpose: We ensure that all documents related to the device’s design, manufacturing, and quality are properly controlled and maintained, particularly in relation to managing a 500,000 LKR grant which necessitated the management of approximately 100 documents.
Document Creation and Review: We develop and review key documents such as design specifications, manufacturing instructions, and quality control procedures. For instance, we have created and reviewed a Standard Operating Procedure (SOP) for sensor calibration, ensuring it is approved by the quality team.
Document Changes: We implement a structured process for managing document changes.
Document Storage and Retrieval: Documents are stored in a secure, organized manner to facilitate easy retrieval. Electronic records of design and production documents are maintained in a document management system with version control.