Make sure that your employees are trained on your QMS and how to use your procedures. Rook delivers custom training for our consultants, focusing in on the important processes for each company.
Int'l Regulatory Compliance
Rook will work to help your company achieve international device approval including CE Mark, Health Canada, China, Australia, and other markets through on-site audit support and regulatory communication.
Quality Consultants will create a custom QS for your company that is efficient and easy to maintain for your product and scope. Our systems are audit ready and continually updated so to ensure compliance with effective regulations.
Rook Consultants will work with your company to develop a comprehensive risk management platform for products and processes, including the use of PHAs, FMEAs (process, use, design, and software), etc.
DHF/ TF Creation
Quality Engineers will help to create your device Design History File and/or Technical File to ensure compliant design control, risk management, design transfer, and manufacturing oversight.
Developing your device in a controlled manner is critical to the company's success. Rook will work to ensure your outputs are verified to meet your inputs and work with you through the verification and validation of your device.
Certified Auditors will conduct internal or supplier audits, and provide support during an external or regulatory audit, including FDA, MDSAP, ISO 13485:2016, and MDR audits.
Rook Consultants can provide validation and testing strategies and support for software. Including SaMD, apps, and QMS software to ensure Regulatory Compliance with ISO 13485:2016, IEC 62034/82304, and IEC 60601.