Compliance

Regulatory Approvals& Quality Assurance

BioView platforms meet the requirements of both research and clinical laboratories

Regulatory Approvals

Cleared for clinical use across global markets.

BioView's imaging and analysis platforms have received multiple regulatory approvals for several applications in many countries worldwide.  Use BioView IVD products only within the scope of their intended purpose and the regulations of the respective country or region.

FDA (US) logo
FDA (US)
EU-IVDR (EU) logo
EU-IVDR (EU)
NMPA (China) logo
NMPA (China)
MFDS (Korea) logo
MFDS (Korea)
TGA (Australia) logo
TGA (Australia)
Health Canada logo
Health Canada
AMAR (Israel) logo
AMAR (Israel)

Quality Assurance

ISO 13485:2016 certified Quality Management System.

BioView's QMS complies with the requirements of ISO 13485:2016 for medical devices - governing design, manufacturing, distribution, and post-market surveillance of every product we ship.

Code of Conduct

The principles that guide how we do business.

BioView's Code of Conduct applies to all employees and officers of BioView Ltd. and BioView Inc., as well as our agents and representatives. It sets out the ethical standards that govern every decision we make - from compliance with the law to how we treat customers, partners and one another.

Violations may result in disciplinary action, up to and including termination, and may also carry civil or criminal penalties.

Download Code of Conduct (PDF)

Accessibility

Committed to an accessible web experience.

At BioView, we are committed to promoting accessibility so that people with disabilities and special needs can use and enjoy the full range of services we provide- at our offices, on our website and through our support channels. Our site complies with Israeli Standard 5568 at AA level, in line with WCAG 2.1.

Download Accessibility Statement (PDF)

Have a question? We're here to help.

Reach out to our team and we'll get back to you within one business day.