Risk management according to ISO14971; “Medical Device” and ISO22442; “Biological Tissue”

ISO 14971 is the nine-part standard which is the framework for risk analysis, evaluation, control, and review of medical devices.

Endotoxins are a special type of end-points in risk management mitigated in ISO22442. Biological tissues vary in consistency, and validation of sourcing gets crucial. The reduction of potential toxins — ranging from biofilms to sponges — are also fundamental in order to prepare your medical with biological tissues.

INSKATO, with its broad competencies and long experience, is able to support to integrate your risks within your product development, and also to reduce and mitigate risks occurring internally, from customers, or authorities.

INSAKATO also possess profound knowledge of the main biological tissues applied in medical devices, and is able to support to minimize risks for your product, either in development phase or during production.