Supporting Medical Device Companies on their Development Journey and Beyond
The medical device market is rapidly changing. New technologies are leading to ever tighter integration of drugs, devices and biologics, as well as software, electronics and physical products. New regulations are driving the industry towards new approaches for safety, device identification and clinical investigations, to name just a few areas.
Increasing pressure on regulators is being passed on to manufacturers and importers. The need for a cross-functional collaboration between Clinical, Regulatory, Quality and Safety is critical to navigate the challenges posed by the regulatory and vigilance requirements specified in the latest European Union Medical Devices Regulations (EU MDR), FDA’s Combination Product requirements for registration and submission of postmarket reports, FDAs Unique Device Identification (UDI) as well as Japan Medical Device Regulations. These regulations necessitate a proactive collaborative and global approach to manage Device and Combination Products in your portfolio to ensure compliance while staying efficient.
Navitas Life Sciences Supports Medical Device Companies Throughout the Product Lifecycle
At Navitas, we have a track record of successful medical device project delivery across many areas, including regulatory affairs, quality management, risk management, device vigilance and track & trace technologies. We offer deep industry insight, paired with project management experience, and work along the three dimensions of processes, people and technology.
Successful Track Record Across
Track & Trace Technologies
We serve clients from the life science industry across multiple regions. We deliver services, technologies, and consultancy engagements to the medical device, biotech, and pharmaceutical sectors. We pride ourselves on our industry leading Networks, setting us apart from our competitors. We are happy to work in large or small teams, depending on the assignment and client requirements. We focus on customer needs and measure both progress and success. Our staff are expert navigators, fulfilling the role of project manager as well as being subject matter experts, delivering value from day one.