Regulatory Compliance

Many of our clients work in highly-regulated industries that carry specific compliance requirements. Ripple Design personnel have extensive experience working in highly-regulated industries and complying with associated regulatory requirements. We pride ourselves in providing thorough, complete documentation that meets and exceeds the most stringent regulatory standards.

• Medical product development compliant with all relevant standards and regulations, including: IEC 60601 series, IEC 62304, ISO14971, IEC 60529, 21 CFR 820
• Regulatory strategy consulting
• Prepare products for UL listing or CE marking
• Develop quality management systems (manuals, procedures, forms, etc)
• Design to nuclear industry standards and regulations (NQA-1, ASME Section VIII)
• Design to military prototype and production guidelines (MIL-STD, ITAR)