Urgently Needed: QMS System for Medical Device

Our client is currently seeking a highly efficient Quality Management System (QMS) and ISO 13485 documentation for their Class-1 medical device, which has successfully undergone both clinical assessment and the registration process. However, in order to ensure its deployment in the real world, a robust QMS is imperative. To accomplish this, we are in need of an expert regulatory professional who can collaborate directly with the client to produce the necessary documents. While numerous templates are readily accessible online, it is crucial to have the guidance of seasoned experts who possess their own specifically tailored documents. Should you possess the expertise required, please do not hesitate to inform us of your availability to assist the client. Key Requirements: - Although specific features have not been finalized yet, the required QMS should be flexible and customizable for possible needs such as document control, training management, and corrective and preventive actions. - While the scale of implementation is simple, the system should be robust and adaptable to cater to various departments if required. - This project is in urgent demand, hence a quick turnaround time is essential. Ideal Skills and Experience: - Proven experience designing and implementing QMS systems, preferably within the medical device industry. - Familiarity with ISO 13485 standard - Strong project management skills to deliver within tight timelines.