We are your expert strategic IVD and Device development partner streamlining the success of your envisioned product bringing your aspirations to life and promising a better health tomorrow.
Be it Over-the-Counter (OTC) or Point of Care (POC) in Vitro Diagnostic Device, we have the right solution for your Product Development and Commercialization. Careful strategic planning and right support through the regulatory pathway will speed up the process of entering the market.
Developing a medical device is a complex process. We understand the nuances of the regulatory process. We partner with you through out the process of strategic planning, clinical trial and submission under right classification, be it PMA, Denovo or 510K.
Ascenth is a full-service CRO providing Clinical Trial Management services for the Global IVD and Medical device Industry, while maintaining highest quality, ensuring strict adherence to your trial timeline and budget through collaborative approach.
From protocol design to project management, data analysis to Regulatory consulting and study submission to meeting with FDA, we provide solution from Inception to commercialization. We ensure your unique needs are met with our flexible approach and optimal support in predefined timelines.
Quality, commitment and trustworthiness are the core principles of Ascenth.
In the intricate world of healthcare diagnostics, the quality and safety of In Vitro Diagnostic (IVD) devices are paramount. As a
In the ever-evolving landscape of healthcare, In Vitro Diagnostic (IVD) technologies stand at the forefront of innovation and precision. As a
The journey of medical device design and development is a fascinating and complex process, encompassing various stages from the initial concept
Full-service medical device CRO and a one-stop shop for clinical and regulatory services.
