Regulatory Services

Quality Management Systems

When you deal with any manufacturing you know that quality must be first and foremost. This is especially true with medical devices. 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

Creation and submittal of an FDA Pre-market submission, [or 510(k)] can be a struggle for many companies. A lot of "i's" need to be dotted and a lot of "t's" need to be crossed. SCG can 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

Today, everything about the development and marketing of medical devices revolves around Risk Management. Required by regulated bodies is adherence to the IEC/ISO 14971:2019 Application of risk management to medical devices. This includes risk analysis from 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. And, SCG has been an active participant in the ISO Joint Working Group to amend and publish Amendment 2 update. The involvement  in this standards development has gained SCG 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.