Medical Device
Artificial Intelligence
See how BioVision’s AI experts
can assist you with the
FDA and MDR’s Regulation
BioVision has the expertise to help your
business succeed worldwide
FDA Consulting
We provide complete FDA consulting and FDA approval services for 510k submissions, and
FDA Quality System Regulations QSR compliance.
EU MDR
BioVision’s consultants are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the MDR.
AI medical device regulation
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.
Quality Assurance
Involving you in every step of the process together we establish, implement and maintain your Quality Management System.
Regulatory Affairs
We provide expert advice on regulatory strategy across the lifecycle of the device, from development until post-marketing stages.
Pre-Clinical and Clinical Affairs
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.
Sterilization Validation
BioVision has vast experience in validation and testing at your disposal to help define the most efficient path forward for this critical processing step.
Outsourcing
BioVision's Outsourcing services offer you quality staff when and where you need it.
Due Diligence
Regulatory and Quality due diligence audits for management, board members or investors of medical device companies.