We provide complete FDA consulting and FDA approval services for 510k submissions, and

FDA Quality System Regulations QSR compliance.

​

​

BioVision’s consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR.

​

​

For manufacturers of AI-based medical devices, the question arises as to which regulatory requirements their medical devices must comply with if they want to use AI. This is where BioVision’s AI experts can assist.

Involving you in every step of the process together we establish, implement and maintain your Quality Management System.​

​

We provide expert advice on regulatory strategy across the lifecycle of the device, from development until post-marketing stages.

​

We support all of your pre-CE clinical studies and

Post-Market Clinical Follow-up challenges.  Together we will secure sufficient clinical

evidence to satisfy the regulator. 

BioVision has vast experience in validation and testing at your disposal to help define the most efficient path forward for this critical processing step.

BioVision's Outsourcing services offer you quality staff when and where you need it.

​

​

Regulatory and Quality due diligence audits for management, board members or investors of medical device companies.

​