Request for service
Request a call
Application for medical device development service
Application for Medical Device QMS Service
Application for medical device registration service
Application for registration of medicines
Request for service of amendments to RC/RD
Request for marketing research service for MD and Pharmaceuticals
Application for technical and medical translation
Order service Strict adherence to standards and innovation at every stage from idea to product release.
Medical device development
The goal of developing MI is to create a safe, effective and user-friendly product that meets all necessary regulatory requirements and solves healthcare problems.
The development of medical devices (MD) is a knowledge-intensive, complex and multi-stage process of creating a new MD, which goes from the idea to its serial production and application in medical practice.
Medical products we design
Medical devices and equipment
Medical furniture
Medical plastic products
Prostheses and implants
IVD medical products
Other products
Key stages of the proces
We offer comprehensive services for the design and development of medical devices, where at each stage we guarantee careful planning, coordination of all project participants and constant quality control of the work performed
At this stage, information is collected about the needs of the client and end users of the medical device. A market analysis is carried out, existing solutions are studied, deficiencies and unmet needs are identified. A detailed specification document is compiled, which includes functional, technical, user and regulatory requirements for the product. Definition of needs and project specifications.
Defining project needs and specifications
01
Based on the collected information and defined specifications, the team develops conceptual solutions for the medical device. This stage includes the generation of ideas, their visualization and an initial assessment of possible solutions. The most promising concepts are selected for further detailed development.
Conceptual
design
design
02
Development of a detailed design of the selected concepts, including engineering modeling, selection of materials and components. Creation of CAD models, diagrams and drawings. This stage also involves creating and testing prototypes of the product to verify compliance with specifications and functionality.
Detailed design and prototype development
03
Conducting preliminary tests to confirm that the developed prototype meets all pre-established requirements and standards. Verification is aimed at checking the design’s compliance with specifications, while validation ensures that the final product meets the needs and expectations of users.
Verification and validation
04
Optimizing the design for mass production, planning production processes, selecting and preparing production facilities. Developing and approving the final documentation required for production.
Preparation for production
05
After the product is introduced to the market, its operation is monitored, and feedback is collected from end users and medical professionals. This stage includes analyzing the product’s performance in real conditions, identifying possible problems and the need for modifications or improvements.
Post-launch monitoring and feedback collection
06
Our capabilities and competencies
Highly qualified staff with professional education
The company’s staff is composed of specialists with a professional education in chemistry, biology, chemical technology, biotechnology, microbiology, biochemistry and biomedical engineering.
Cooperation with relevant organizations
We cooperate with leading medical universities, medical organizations and manufacturing enterprises to maximize the use of knowledge and experience in the medical field
Unique automated techniques using artificial intelligence
The company uses unique, automated documentation development techniques using artificial intelligence technologies. This improves efficiency and quality of work, as well as allows to optimize costs.
Reliable data protection
The company uses a reliable server for data storage, which provides high level of security and important information preservation.
Continuous monitoring and improvement of the process
We are not standing still and constantly optimizing the process, introducing innovations and modern approaches to the medical device design process
Leave this process to the professionals
Successful design and development of medical products is a complex process that requires the joint efforts of engineers, designers, medical professionals and managers.
Services within the framework of MD development
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
Our Medtech Business information resource on telegram. Legislative changes, market overview and science in the field of medical devices.
