Regulatory Services
Quality Management Systems
When you are a manufacturer of a medical device, you know that quality must be first and foremost. This is especially true with evolving regulatory requirements and adoption of ISO 13485 by FDA. A Quality Management System is not just important, but it is required to market medical products. Compliance with FDA and ISO regulations can be confusing and difficult. SCG can assist in setting up your QMS to meet those requirements.
FDA Premarket Notification
SCG has helped many companies negotiate the FDA 510(k) pathway to market their medical device. The 510(k) can be a struggle as a lot of "i's" need to be dotted and a lot of "t's" need to be crossed. SCG can manage the entire submittal, or guide you through this process to ensure the submission is complete and thorough to get you to market as quickly as possible.
Medical Device Risk Management
The development of a medical device requires the implementation of a Risk Management process as required by regulated bodies. Standards state explicitly that design and development is performed using Risk Management. Typically, this is adherence to ISO 14971:2019 Application of risk management to medical devices and the associate technical report TR 24971 which provide guidance on the application of the standard. This includes risk management activities from product concept, design, product realization, and through post-market activities. SCG can evaluate your risk management activities, update as needed, or create a new process from scratch.
Alarm Management
With extensive background in patient monitoring, SCG has been an active member of the ISO/IEC/AAMI Alarms Committee and the AAMI National Coalition for Alarm Management Safety. The involvement to develop this standard includes the understanding of Alarm Fatigue and knowledge of what needs to be done to manage alarms in critical settings. We can evaluate your process and help you to implement workflow and procedures to manage alarms effectively.