Medical device consultants For Your Medical Device Business
As professionals in the health area, Medical device consultants have the responsibility to know the health regulation and apply it to comply with it, thus favouring regulatory processes, exercising our profession with responsibility.
The US market constitutes approximately 46% of the world market for medical devices, IVDs, cosmetics, biocides and PMCs.
Companies have generally addressed the approach to the marketing of medical devices, IVDs, cosmetics, biocides and PMCs in the United States by entrusting the task of obtaining FDA approval to the first retailer or agent with whom an agreement has been entered into. Commercial collaboration. In this case, there are not a few hidden pitfalls behind this choice. The main one concerns the ownership of the “FDA certification”, which will not belong to the manufacturer but the local dealer.
Role of Medical device consultants
Many medical devices require a substantial equivalence letter from the FDA stating that the device intended for sale is as safe and effective as other similar devices on the market. This is obtained by requesting premarket approval (501k). Medical device consultants can assist your company in the application process. High-risk under Class III devices require premarket approval by the FDA before they can be sold in the US. This can be a complicated process, as it requires the submission of clinical evidence of safety and the effectiveness of the device. Medical device consultants offer a full pre-market approval application service that ensuring your application meets all FDA requirements.
For devices intended for use in the treatment or management of patients with rare diseases, it may be challenging to meet the requirements for pre-marketing approval, as there is limited clinical evidence. In cases like these, the Humanitarian Devices Exemption (HDE) may be granted. Can help your business apply for HDE.
To meet the requirements for premarket approval, clinical trials of medical devices must be conducted. There is a special permission for the use and sale of devices in this context, known as the “Research Device Exemption” (IDE). Medical device consultants can help your business apply for this exemption.
Brand new devices are automatically classified as Class III devices as it is not possible to complete an equivalence assessment with other devices. If your device poses a low risk, you can prove it to the FDA. Medical device consultants can help your business through this process to ensure your device is classified as quickly as possible.
- New Records
- Technical Modifications
- Administrative
- Extensions
- High Techno vigilance
- Techno vigilance Report
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