Igavia Science

09/24/2025

Our regulatory expertise is not limited to a single specialty. We provide precise and strategy for medical devices across all clinical domains—including cardiology, surgery, orthopedics, respiratory care, neurology...

No matter your device's application, we ensure your pathway to is efficient and compliant.



Developing a Device? Our Expertise Covers Your Specialty.
Let's Talk: howdy@igaviascience.com

09/19/2025

Behind every device that restores mobility, relieves chronic pain, or supports neurological recovery —there’s science, strategy, and regulatory precision. Igavia Science empowers innovators in physical and neurological medicine to bring ideas to life. If You Are Developing Medical Devices, Let’sTalk 📧howdy@igaviascience.com

02/26/2025

The FDA has recently issued multiple news releases and statements regarding breast implants, including safety alerts, labeling updates, and new requirements that all medical device manufacturers must comply with.
If you're a medical device manufacturer, it's crucial to stay ahead of these changes to ensure your products comply with FDA regulations. We specialize in helping companies navigate the complex world of FDA registration, so you can focus on what you do best—creating life-changing devices.
Partner with us to ensure your medical devices meet the latest FDA standards. Let's work together to make sure your products are compliant and market-ready.

🔛 Contact us today for more information and a consultation! Let's help you navigate these new FDA regulations with confidence.

https://linktr.ee/igaviascience?utm_source=linktree_profile_share<sid=bb52cb19-4bc6-4d84-850a-12307d6b18b3&fbclid=IwY2xjawIsV9JleHRuA2FlbQIxMQABHY2tQZyap9qW90WiLVFPK3Wa-JedQU7gBRQPPo--fen___o8Ga3_bM-RKQ_aem_zCI_tE3zOkD4AxHC50DeaA
Partner with us to ensure your medical devices meet the latest FDA standards. Let's work together to ensure your products are compliant and market-ready.

10/31/2024

10/21/2024

WinWork@igaviascience.com

10/16/2024

Regulation of medical device products in the U.S. and LatAm and maintenance of the approved medical products.

12/01/2023

➡ By 2024, your company will undoubtedly be planning new projects, targets and regulatory challenges requiring accurate, fast and reliable information.

▶️ Start planning your year now, and consult with experts on medical devices and their regulation in the US.

👥 Our team is at your disposal to answer all your questions.

More information available here: 👇

🌐 www.igaviascience.com

#2024

11/29/2023

👨‍💼 Do you know what could be the reasons for the invalidity of your registration number?

👉 Swipe to find out what the main reasons may be.

⚠ Remember that at Igavia we can verify your US FDA registration to easily check if your product registration is valid and take corrective action to avoid potential fees or fines.

Consult us now, and avoid problems in the future:

🌐 www.igaviascience.com

11/17/2023

📚 Discover the secrets behind establishing a medical device risk class!

🏥💡 Get all your questions answered in our FAQ at Igavia.

📖 Stay informed!

11/08/2023

➡️ ¿Su empresa necesita expandir su mercado?

✅️IGAVIA es la solución para que tus productos ingresen al mercado estadounidense.

👨🏻‍💼Contamos con agentes certificados por la FDA capaces de guiarte en todas las etapas del proceso.

Somos especialistas y queremos trabajar en equipo contigo.

Contacta ahora mismo y recibe toda la información:👇

🌐 https://igaviascience.com/

11/03/2023

📣 News about labeling considerations for devices containing lubricious coatings used in the vasculature.

👉 The purpose of this post is to provide the medical devices industries recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting.

👨‍⚕️ Since these recommendations are based on known safety issues, FDA recommends that this information be considered for inclusion as current product labeling is updated, and that labeling included as part of future premarket submissions for intravascular devices with lubricious coatings incorporate the recommendations.

Consult now and get personalized advice from the experts:

🌐 www.igaviascience.com

10/30/2023

👉 Learn about the benefits of obtaining FDA certification for your Industry
Registration with the FDA is easy.

👤 The US Food and Drug Administration (FDA) is responsible for protecting public health by regulating imported products.

✅ Any company that plans to distribute food, animal, medical, or beauty products for the U.S. market must register with the FDA.

🙌 Registration may seem complex, but it is not. At Igavia Science we have specialized agents willing to assist you at every stage of the process.