Start-up?
We understand the importance of reaching strategic milestones.
That’s why we offer our assistance to ensure your success.
Field experts with years of experience
We design invincible startups
Every start-up is different. Each time it’s a journey from 0 to1. There are tens of thousands of such ventures in the world – there are already methods on how to do it. We offer knowledge, experience and commitment at every stage of doing innovative business. We help you protect IP, prepare a strategy for raising capital, prepare materials for investment funds, manage R&D work, test the business model, build a secure (as far as we can) future Innovation Driven Enterprise (IDE). We specialize in Medtech and LifeScience but are not closed to other industries.
Proven methods for designing medical devices
Designing medical devices is not only about meeting regulatory and technical requirements, but also about understanding the needs and expectations of patients and users. At our company, we use proven methods that combine scientific knowledge, practical experience and innovative processes to create state-of-the-art solutions. Our team consists of qualified specialists from various fields who collaborate at every stage of medical device design and development. We are experienced in conducting research and development and feasibility studies. We will help you plan your knowledge management process to deliver innovative products more reliably and on time.
In Vitro Diagnostic Devices
Designing in vitro diagnostic devices(IVD) requires not only meeting stringent quality and safety standards, but also ensuring clinical efficacy and reliability of results. At our company, we offer comprehensive services for the design and certification of IVD devices in accordance with the new EU regulation (IVDR). We use the latest technologies and testing methods to ensure the highest quality and accuracy of the IVD devices we design.
MDR i IVDR Directives
The MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) regulations are new European Union regulations on medical devices and in vitro diagnostic medical devices. These regulations introduce numerous changes and requirements, including scope of use, classification, conformity assessment, device identification, market surveillance, clinical trials and clinical data, obligations of economic operators, device tracking and monitoring, and information for patients and users. Our specialists will guide your company through the complex process of bringing your products into compliance with the current standards.
NIS2 Compliance
The NIS2 Directive is the latest regulation aimed at achieving a high common level of cybersecurity. This new regulation introduces numerous cybersecurity requirements and expands the scope of sectors and departments, both public and private, that must comply with its mandates. These sectors include Healthcare, Digital Services, Key Infrastructures, Energy, Transportation, Banking, Financial Markets Infrastructure, Water Supply, Waste Management, Public Administration, and Space. The introduction of the NIS2 Directive is crucial for enhancing EU-wide resilience to cyber threats and represents a significant step towards ensuring the digital security of citizens, businesses, and public institutions in Europe. The directive also emphasizes the need for organizations to continuously adapt and improve their cybersecurity measures. Our specialists are here to help your company navigate this complex process and ensure compliance with the NIS2 Directive.
Information Security, Cybersecurity, and Data Analytics in Medical Devices
In the digital age, information security, cybersecurity and data analysis are key aspects of medical device development and use. At our company, we ensure that our medical devices are protected from cyber threats such as hacking attacks, data theft, malware and system failures. We adhere to the highest security and compliance standards. At the same time, we leverage the potential of data analytics to improve the quality and performance of our medical devices, tailoring them to the needs and preferences of patients and users. Our team has extensive experience in implementing MDCG 2019-16 and security standards such as ISO 27001, 27018, 27799, SOC1, SOC2 and SOC3.
Certification at Your Fingertips
Ensuring that a medical device complies with certification standards is not just a formal requirement; it is a proof of its quality and safety. Avoid the pitfalls of delays, complications and additional costs associated with incorrect or incomplete documentation. Rely on our experience. Our company excels in preparing comprehensive project documentation for certification, offering a comprehensive service and personalized approach.
Streamline Your Business
Effective business process design is crucial for success in the medical technology industry. Inefficient processes can lead to financial losses and hinder project completion. We offer our expertise in designing and optimizing business processes tailored to your specific needs, goals, and market demands. Our team of experienced professionals excels in project management, business analysis, process modeling, automation, and systems integration. Partnering with us will not only enhance your efficiency and save you time and money but also provide you with a competitive edge.
Business Education
Business coaching is a professional service designed to help you achieve both your professional and personal goals. Regardless of your position, an experienced coach will help you discover your strengths and the strengths of your business, identify your needs and challenges, and develop a strategic action plan. With their guidance, you will realize your vision and grow your business. The competencies you gain will benefit not only your business, but also your personal life.