Medical technologies are strictly regulated in the European Union and on an international level. Manufacturers must meet various requirements and standards before a medical product can be legally placed on the market. The regulatory requirements frequently change and are becoming more and more complex, thus making the approval process increasingly demanding. Our certification and regulatory experts understand the challenge of developing medical products for global export and can help to ensure the compliance and conformity of your product and speed up its market launch.
Bertrandt Medical has many years of experience in the validation of equipment, processes, and systems used in a wide range of applications for medical products. We apply our experience in the regulation of medical products and in-vitro diagnostics to ensure that all the necessary documentation, certification, and compliance requirements for your product are complete, thus creating the conditions for a successful market launch. Our service package is rounded off by flawless technical documentation.
To make sure that your medical product complies with the regulatory requirements and standards, our engineers and scientists understand the technical procedure and will work closely with you to tailor validation projects precisely to your needs.
