by Johari Digital | Nov 30, 2022 | Engineering, Regulatory
A Medical Device Contract Manufacturing Organization is never at rest. With diversity of projects from different segments of Medical Device Industry, the possibilities of errors, risks, and upgrades are infinite. Every new project comes with its challenges and...
by Johari Digital | Sep 1, 2022 | Medical Device, Regulatory
Risk Management in Medical Devices is a complex process and requires a strategic approach requiring careful analysis of steps involved in the manufacturing process. ISO 14971 requires specific practices meant for strategically implementing risk management in a Medical...
by Johari Digital | Feb 15, 2022 | Medical Device, Regulatory
What is SaMD? As per FDA, the term Software as Medical Device (SaMD) is Defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Any software that helps...
