You are a manufacturer of medical devices you have to create a technical documentation or the quality manual as stipulated by law? You would like to apply for an HMV code or would like to be successful abroad? You have the knowledge, but find yourself at full capacity when it comes to the implementation?
BEO BERLIN will compile CE/QM documentations, HMV-applications and evaluations for you.
We will prepare your QM documentation including all required procedures.
We will prepare your technical documentation with the required reports.
We register manufacturers and list their products nationally and internationally.
I am developing a new medical device. Do I always have to provide evidence of its medical benefits via a clinical investigation?
BEO BERLIN can take over responsibility for the clinical evaluation and clarify whether sufficient validation is available in the literature.
I am a manufacturer of a Class I medical device. Do I need a certified quality management system? The Medical Devices Regulation (MDR) will be the sole legislation in force as of 26 May 2021. According to the MDR, all manufacturers are required by law to introduce and document a quality management system for the processes required under the Regulation. BEO BERLIN can draft the required documents and templates for you in compliance with the new statutory requirements.
I would like to update my existing documentation, and have it checked to ensure it is complete.
BEO BERLIN can evaluate and inspect your documentation and provide you with a plan of action to address any issues.
