Rarity Bioscience Achieves ISO 13485 Quality System Certification

We can now proudly announce that Rarity Bioscience have achieved the ISO 13485:2016 certification from BSI!

The achievement emphasizes Rarity Bioscience’s commitment to becoming a trusted and reliable partner in research, diagnostics, and therapeutics. Attaining this certification sets Rarity Bioscience apart from other early stage biotech startups in the rapidly evolving field of diagnostics.

This certification demonstrates our dedication to quality and serves as a foundation for our vision to democratize mutation detection through sensitive and reliable technology.

– Hanna Kocken, Director of Quality and Regulatory at Rarity Bioscience AB


About ISO 13485

ISO 13485:2016 is an internationally recognized standard for quality management systems in the medical device industry. It provides a robust and reproducible framework for designing, developing, and manufacturing products that meet customer-, safety-, and regulatory requirements.

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