M.K. Medical Device Solutions

About M.K. Medical Device Solutions

M.K. Medical Device Solutions provides turnkey design and consulting services for medical devices, ensuring compliance with FDA and CE regulations through adherence to standards like IEC 60601 and ISO 13485. The company addresses the complexities of medical device development by offering expertise in electronic and mechanical design, embedded software, and battery solutions, minimizing costly design changes and enhancing product reliability.

```xml <problem> Medical device companies face challenges in navigating complex regulatory landscapes, including FDA and CE requirements, which can lead to costly design changes and delays in product launches. Ensuring compliance with standards like IEC 60601 and ISO 13485 requires specialized expertise across various engineering domains. </problem> <solution> M.K. Medical Device Solutions offers comprehensive design and consulting services to streamline medical device development and ensure regulatory compliance. The company provides turnkey solutions, guiding clients through the entire process from initial concept to market release. By offering expertise in electronic and mechanical design, embedded software, and smart battery solutions, M.K. Medical Device Solutions helps minimize design iterations, enhance product reliability, and accelerate time to market. Their consulting services provide expert advice on device certification according to medical standards, helping companies navigate the complexities of the medical device industry. </solution> <features> - Turnkey medical device design following medical standards for FDA approval and CE marking. - Expert consulting on medical equipment design and certification (IEC 60601, ISO 13485). - Electronic design services to prevent costly and time-consuming design changes. - Mechanical design considering biocompatibility, usability, shelf life, and reliability. - Flexible embedded software design complying with IEC 62304 safety standards. - Smart battery solutions optimizing reliability, cost efficiency, weight, energy, and safety. </features> <target_audience> M.K. Medical Device Solutions primarily serves medical device companies, both small and large, seeking expert guidance and support in navigating the complexities of medical device design, development, and regulatory compliance. </target_audience> ```

What does M.K. Medical Device Solutions do?

M.K. Medical Device Solutions provides turnkey design and consulting services for medical devices, ensuring compliance with FDA and CE regulations through adherence to standards like IEC 60601 and ISO 13485. The company addresses the complexities of medical device development by offering expertise in electronic and mechanical design, embedded software, and battery solutions, minimizing costly design changes and enhancing product reliability.

When was M.K. Medical Device Solutions founded?

M.K. Medical Device Solutions was founded in 2022.

Who founded M.K. Medical Device Solutions?

M.K. Medical Device Solutions was founded by Vyacheslav Solomanidin.

  • Vyacheslav Solomanidin - Co-founder
Founded
2022
Employees
2 employees
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M.K. Medical Device Solutions

Score: 17/100
AI-Generated Company Overview (experimental) – could contain errors

Executive Summary

M.K. Medical Device Solutions provides turnkey design and consulting services for medical devices, ensuring compliance with FDA and CE regulations through adherence to standards like IEC 60601 and ISO 13485. The company addresses the complexities of medical device development by offering expertise in electronic and mechanical design, embedded software, and battery solutions, minimizing costly design changes and enhancing product reliability.

mkmeddev.com100+
Founded 2022

Funding

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Team (<5)

Vyacheslav Solomanidin

Co-founder

Company Description

Problem

Medical device companies face challenges in navigating complex regulatory landscapes, including FDA and CE requirements, which can lead to costly design changes and delays in product launches. Ensuring compliance with standards like IEC 60601 and ISO 13485 requires specialized expertise across various engineering domains.

Solution

M.K. Medical Device Solutions offers comprehensive design and consulting services to streamline medical device development and ensure regulatory compliance. The company provides turnkey solutions, guiding clients through the entire process from initial concept to market release. By offering expertise in electronic and mechanical design, embedded software, and smart battery solutions, M.K. Medical Device Solutions helps minimize design iterations, enhance product reliability, and accelerate time to market. Their consulting services provide expert advice on device certification according to medical standards, helping companies navigate the complexities of the medical device industry.

Features

Turnkey medical device design following medical standards for FDA approval and CE marking.

Expert consulting on medical equipment design and certification (IEC 60601, ISO 13485).

Electronic design services to prevent costly and time-consuming design changes.

Mechanical design considering biocompatibility, usability, shelf life, and reliability.

Flexible embedded software design complying with IEC 62304 safety standards.

Smart battery solutions optimizing reliability, cost efficiency, weight, energy, and safety.

Target Audience

M.K. Medical Device Solutions primarily serves medical device companies, both small and large, seeking expert guidance and support in navigating the complexities of medical device design, development, and regulatory compliance.

M.K. Medical Device Solutions | StartupSeeker