We specialize in certifying a wide range of medical devices, including but not limited to Active medical devices, Invasive and Non-invasive devices, Software as Medical Devices (SaMD), Diagnostic equipment, Surgical instruments, Implants, In-vitro diagnostic (IVD) devices, Single-use disposable devices, Devices with measuring function, Devices with no medical intended purpose, Systems and procedure packs, Drug-devices combinations, Sterile medical devices, Re-usable medical devices and many more.

The duration of the certification process varies depending on the complexity of the device and the regulatory requirements. This will also depend on how soon we receive the requested data from the client and the current level of documentation held by them. We can provide an estimated timeline after evaluating the specifics of your product.

The certification process generally involves regulatory strategy development, documentation preparation, submission, and interaction with regulatory agencies. This may also include relevant product testing and coordination with other external agencies. We guide you through each step to ensure a smooth process.
Do you provide post-certification support?

Yes, we offer post-certification support to help you navigate any post-market surveillance requirements, address changes to your device, and stay compliant with evolving regulations. We have 3 different plans in place depending on the level of support required by the manufacturer to maintain their regulatory obligations.

The cost of certification varies based on factors such as the type of device, classification, regulatory pathway, cost of external agencies like consultation, testing, UDI, Clinical trials, liability insurance, and geographic markets where the manufacturer wishes to apply. We can provide a customized quote after understanding your specific needs.

Absolutely, we have expertise in navigating global regulatory landscapes and can help you obtain certifications for international markets, ensuring a seamless entry into different regions. We also assist with license holding and registration support in more than 50 countries.

Getting started is easy! Simply contact us through our website, and we’ll schedule a consultation to discuss your specific needs and outline a tailored plan for your medical device certification journey.