Our 3D-manufactured part classifies as a Class I medical device. Essentially, it is simple in design and provides little to no potential risk for end users. This device is also non-implantable and will not be used in a clinical environment (e.g. the operating room (OR)). In order to provide proper risk assessment, we will perform a Device Failure Modes Effects and Criticality Analysis (DFMECA) and User Failure Modes Effects and Criticality Analysis (UFMECA). These risk assessments consider all probable nonconformances and we expect that the risk to the end user is ‘Negligible’.
Our VR-simulation system also classified as a Class I medical device. Like the 3D-manufactured part, it is also simple in design and provides little to no potential risk for end users. Likewise, this device is and will not be used in a clinical environment (e.g. the operating room (OR)). We will also be performing DFMECA and UFMECA and expect that the risk to the end user is ‘Negligible’.
Because we are developing Class I medical devices, we must adhere to the FDA standards associated with it. In particular, we must adhere to the Code of Federal Regulations, Title 21, Part 820 (commonly known as 21CFR820) which includes documentation of general provisions, quality systems requirements, design controls, document controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product, corrective and preventative action, labeling and packaging control, handling, storage distribution, and installation, records, servicing, and statistical techniques. Essentially, we must adhere to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Besides providing documentation for adherence to FDA standards, we will be pursuing a 510(k) premarket notification which is used to demonstrate that the device to be marketed is substantially equivalent to a legally marketed device. Most Class I medical devices are exempt from the 510(k) due to interchangeability with an already commercialized medical device. However, our device in particular serves a novel purpose that is equivalent to a legally marketed non-medical device so we ultimately have to pursue the 510(k) strategy for FDA approval.
We eventually want to branch out to international markets and as such, one of our goals is to receive the CE mark which indicates that the product complies with the essential requirements of European health, safety, and environmental protection legislation. In order to achieve this, we need to adhere to international standards including ISO 13485:2016 which encompasses requirements for regulatory purposes specifically for medical devices. This includes documentation of quality management system (QMS), management responsibility, resource management, product realization, and measurement, analysis and improvement. After establishing compliance to ISO standards and since we expect the end product to have minimal risk, the next step would be to prepare a Declaration of Conformity.