Medical Device Certification
2M Engineering possesses extensive expertise and knowledge in the field of medical device certification. We offer comprehensive support throughout the entire certification process, including defining and validating the intended use, conducting thorough risk analysis, selecting relevant standards, performing verification and validation tests in compliance with the standards, and generating the necessary technical product documentation.
Our experience encompasses various device classes, including CE-IVD, CE1m, and 2a/2b products. In certain cases, our organization and sister companies boast ISO13485 certified production facilities.
With a focus on quality management systems, product certification, and regulatory compliance, we can provide partial or full assistance in these areas from the early stages of development to the commercialization of the product.
It’s important to note that medical device certification is not offered as a standalone service but rather as part of client-specific OEM product developments or research projects.
Industrial ATEX device certification
In addition to our expertise in medical devices, 2M Engineering specializes in the development and production of industrial and environmental sensor solutions. Throughout our years of operation, we have obtained ATEX certification for a range of products and solutions, leveraging this experience in our ongoing industrial sensor development endeavors.
It’s important to note that industrial ATEX device certification is not provided as an individual service, but rather as part of our client-specific OEM product development initiatives. We collaborate closely with clients to ensure that their industrial sensor solutions meet the necessary ATEX certification requirements.
Standard CE Certification
Based on the specific application and intended use, 2M Engineering also facilitates standard CE certification, tailored to meet the requirements of various devices such as sports trackers. We take full responsibility for executing the comprehensive CE certification process on behalf of our clients, ensuring compliance with the necessary standards and regulations.