Regulatory Standards: All projects involve compliance with regulations set by recognized standards organizations. We routinely design products to meet various UL, CE, RoHS and FDA regulations. Passing tests and gaining approval is a team effort. The team is the client, Bleck Design Group, the supply chain and other consultants.
Bleck Design Group’s Role: We review the standards and identify each requirement in our design scope. We identify and reduce risks. We create levels of risk mitigation and contingencies for unpredictable outcomes. We evaluate materials and components before design integration. Periodic regulatory reviews with the client’s regulatory staff and third party consultants are normal steps. Early and thorough risk management leads to shorter approval times. For Class I and II medical devices we provide documention complient with ISO 13485.
Client’s Role: The client approves the product for sale. We support the client through testing, provide design documentation, resolve any issues, and help guide the process. If you are a start-up organization, your quality system may be developed concurrently with our efforts. For established firms, our proposal will define our regulatory compliance scope and mesh with your system.