I have to design a medical device. How to demonstrate regulatory compliance?
A medical device must meet one of the directives on medical devices. Regulatory compliance is to gather all the evidence to show that the device is safe and effective.
Firstly, it is important to determine the expected use of the device. Depending on the intended use, it is possible to determine the class of the device and the strategy to demonstrate compliance. Whatever the strategy, there are basic rules to respect, for instance, build a technical file gathering compliance evidence. Evidence includes the device design, risk management, validation of special processes, biological evaluation, clinical evaluation, post production monitoring, etc.
Using nex’file offers:
- A working method based on the STED format;
- A solution that fits all business organisations;
- Expertise easily adopted by the teams;
- Facilitated and reproducible updates;
- The different sections are written by experts in the field.
Nexialist can assist you in setting up the establishment of the technical file and help you during the audit phase of the file.
What are the risks in case of poor preparation?
If you do not have sufficient evidence to establish that the device is safe and effective, it cannot be marketed. If that were the case, you violate the directive and you are liable to penalties of health authorities (marketing suspension, fine, etc.) and especially, very bad publicity for your company.