FDA Consulting

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

FDA Quality System Regulations QSR compliance.

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EU MDR

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

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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.

Cyber Security

BioVision helps medical device manufacturers confidently navigate evolving FDA and EU cybersecurity regulations. As experts in the latest compliance standards, we have a proven track record of FDA and MDR approvals.

Regulatory Affairs

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

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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.

Quality Assurance

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

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Due Diligence

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

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