SilverFit systems are certified medical devices which comply with the requirements of various international standardisation bodies:
- SilverFit medical products comply with the new MDR (Medical Device Regulation) requirements for CE (Conformité Européenne) marking;
- SilverFit medical products are developed in compliance with the IEC (International Electrotechnical Commission) 62304 standards for medical software.
- Our working methods are certified and comply with the ISO (International Organisation for Standardisation) 13485 standard for medical products.
But why would you want such a certification? What do you as a customer and user gain by it?
Buying a certified medical device is important for several key reasons — mainly around safety, quality, legal compliance, and reliability.
Here’s a breakdown:
- Safety and reliability
Devices must pass strict safety checks before they’re allowed on the market .We have also a risk management process to reduce the risks for users as far as possible. - Proven clinical effectiveness
Our products are developed based on proven research. We have written a detailed white paper for each product with multiple research and studies that are available on our website for further information. - Clear instructions and labelling
There is always an updated manual instruction to be found on our systems so you can use it correctly and confidently. Each system is also provided with a label that allows users to identify exactly which product they are using. - Traceability and accountability
Each of our products has a unique identification code, making int easy to determine the exact version in use. - Ongoing safety monitoring
After a system is acquired by a client we still solve cases and follow up on issues and feedback. - Quality manufacturing
Manufacturers follow strict quality rules during production. We have an ISO certified production system that guarantees quality across all products. - Regulatory oversight
Our devices are checked by certified organizations before approval. We are also always open to review of our processes and products if needed. Technical documentation is always available on request. - Data protection and ethics
Patient information must be handled securely and ethically . Therefore we encrypt patient data, we do no have access to patient data of our clients and we reduce the collection of personal information. - Software safety
Medical software must meet safety rules throughout its development. Our software is developed according to international standards and tested before making it available to customers. - Environmental and social impact
MDR supports transparency, sustainability, and responsible business practices. We have a sustainability system to reduce our impact on the environment, we have an ECOVADIS score and we are preparing to get the ISO 27001 certificate (implementation of an information security management system that meets the requirements of the international ISO 27001 standard).
We have gathered all the information on our certifications in an article. Here you will also be able to download the CE mark, the ISO certificate and the Declarations of Conformity (DoC) of all our systems. Also, you will find the links to the European Database on Medical Devices (EUDAMED) for each system.
