ABOUT US
Who We Are
ABOUT THE COMPANY
Biomedista Consulting is a leading firm providing fast and reliable regulatory and registration consulting services to medical device manufacturers and distributors. Established in 2018, our company aims to simplify the complex regulatory requirements for our clients with our experienced team specializing in compliance and approval processes in global markets. We are committed to helping our clients bring their healthcare technologies to the market swiftly and safely.
Reliable Collaboration
Client-Centric Approach
Fast and Accurate Solutions
Our Services
We launch your medical device to a global market.
Compliance with Legislation Worldwide
We provide comprehensive services worldwide such as regulatory consultancy for the Medtech sector, EU RoHS compliance assessment, local legislation monitoring and updates, and management of registration and application processes. We support our clients in all necessary processes to ensure their products comply with local and international regulations through our three offices and local partners.
Product Registration and Follow-Up
We provide follow-up services for product registration process between manufacturers and distributors. As part of this service, we assist our clients with product registration to meet legal requirements, make essential updates, and ensure the continuity of product registration. We aim to facilitate and ensure accurate registration submission process.
Market Access
Our expert team prepares all necessary documentation and maintains regular communication with relevant authorities to ensure market access and reimbursement process. We advocate for stakeholder engagement, conduct economic evaluations, manage HTA processes, and stay updated on policy changes.
OUR MISION
At Biomedista, we're on a mission to be your trusted partner in the complex world of medical device regulations. Our goal is simple yet profound: to help medical device innovators, like you, bring their life-changing technologies to people worldwide. We're here to guide you through the maze of regulations, ensuring your innovations reach the hands of those who need them most.
OUR VISION
Our vision is to lead the way in shaping a world where life-changing medical devices effortlessly find their path to global markets, recognizing that regulatory approval stands as the cornerstone of this journey. We aspire to be the go-to consultancy renowned for our deep industry expertise, innovation-driven solutions, and an unwavering commitment to the success of our clients. Through our collaborative efforts, we aim to revolutionize healthcare access and outcomes worldwide, knowing that regulatory approval is the linchpin upon which transformative technologies are made accessible to those who need them.
