Risk Management
One of our main areas of expertise, with over two decades of experience, we write risk management Standard Operating Procedures (SOPs) and oversee the necessary documentation for virtually every type of project. With our proficiency, we adeptly navigate the risk landscape, minimizing the need for late-stage design changes, thanks to our deep understanding and appreciation of the DFMEA process.
Our diligent approach applies to every analysis and compliance document we handle, including 510(k), PMA, Electrical Product Safety, Software Compliance, Health Hazard Analysis, Clinical Trials, and Internal Review Boards (IRBs).
We can work within your existing risk management processes, facilitating analyses and providing comprehensive documentation to meet all requirements and submission perspectives.
ISO 14971:2007 / EN ISO 14971:2012 – Risk Management
Risk Management Plan
Risk Analyses (PHA, DFMEA, PFMEA, FTA, etc.)
Risk-Benefit Analysis
Additional Services
Project Management
Leading your team or helping you build a new one, to design and develop your product to your exact specifications.
Systems Engineering
Assisting your team in establishing system architecture and product requirements for your product.
Software Quality
Providing IEC 62304-compliant deliverables and quality oversight on processes and execution.