Exclusive Services
Regulatory Compliance
Providing you vital insights on regulatory compliance and deliver up-to-date, robust global regulatory intelligence services to enhance new product development processes. Having more than 20 year experience in different aspects of medical device business, we are ready to arise a regulatory strategy together.
Based on our extensive experience on different areas in medical device, we are a part of your team, dedicated on establishing a robust technical documentation infrastructure to meet regulatory requirements.
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We serve as a regulatory partner and provide you insights to develop a global regulatory strategic roadmap for continuous improvement.
Technical Documentation
A robust technical file is required to release your medical device into the market. Based on our experience on medical devices from Class I up to Class III implantables and softwares, ready to support you on preparation of your technical files.
Project Management
Execution of projects and on time delivery of products is important to meet your strategic objectives. We are ready to support you on project management activities, execution of all kinds of reporting and establishing a close communication structure between your teams.
Quality Management System
A quality management system is often a vital element for your business. Happy to contribute, based on my experience with start-up, global and service companies, to establish a robust quality system and sustainability.
Let's Work Together
From the implementation of medical device strategies to market launch, we are ready to tackle challenges and lead you to success. Since 2018, we have been providing the support needed in many projects at home and abroad.
Contact us now to make an appointment for an interview.