Regulatory

A regulatory strategy for is critical a major determining factor of your development budget and timeline, having a well-defined regulatory plan in place will not only save you valuable time but also help you optimize your budget.

Our track record includes successful development projects with CE marking and FDA approval for various medical devices and in-vitro diagnostic devices and we can support you to find the right solution.

We are familiar with and have received training in the primary standards, required to develop medical devices:

• ISO 13485: Quality Management Systems
• ISO 62304: Medical Device Software Development
• ISO 62366: Human Factors
• ISO 14971: Application of Risk Management
• ISO 61010: Safety Requirements
• ISO 60601: Medical Electrical Equipment