Regulatory
Formal Responsibility Statement
At PlatoScience, we recognise that our duty extends far beyond the engineering of neurostimulation hardware; it is our fundamental responsibility to ensure that every device reaching a user is governed by rigorous safety and quality controls. While we strive for transparency, the ultimate responsibility for maintaining these high standards lies with our dedicated compliance and quality assurance teams lead by the CEO, who monitor the evolving regulatory landscapes across the globe to ensure the ongoing protection and trust of our community.
Understanding Our Regulatory Framework
To provide clarity for both laypeople and experts, we distinguish between our Commercial Terms (covering purchases and returns) and our Technical & Medical Standards. The latter are categorised below:
ISO Standards (Quality Management)
ISO standards are the backbone of our operational integrity. We adhere to these international benchmarks to ensure that our internal processes - from design to data handling - are consistent, traceable, and focused on risk mitigation.
ISO 13485: The specific standard for medical device quality management systems.
ISO 14971: The framework for the application of risk management to medical devices.
Technical Test Reports
Before any product is released, it undergoes exhaustive testing by independent third-party laboratories. These reports verify that our hardware meets strict limits for crucial elements such as electromagnetic compatibility (EMC) and electrical safety, and ensuring the device does not interfere with other electronics.
Medical Regulations
In markets where our devices are classified or utilised as a medical device, we comply with stringent regional frameworks. This includes the EU Medical Device Regulation (MDR) and similar jurisdictional requirements, which mandate rigorous clinical evaluation and post-market surveillance to verify treatment efficacy and safety.
Non-Medical & Consumer Regulations
Even in contexts where our products are used for general wellness or research, we comply with universal consumer electronics safety laws.
CE & FCC: Ensuring compliance with radio frequency and safety standards in Europe and the US.
RoHS & REACH: Verifying that our hardware is free from hazardous substances and environmentally responsible.
Need further details?
Compliance is a continuous dialogue. If you are an expert requiring specific documentation or a user with questions about safety in your region, reach out if you have any questions: