by Johari Digital | Nov 30, 2022 | Medical Device
A Medical Device is as good as its parts, this eventually makes supplier qualification process extremely important in Medical Device Design & Development. FDA 21 CFR 820.50 and ISO 13485:2016 Section 7.4 highlights major requirements for purchasing controls and...
by Johari Digital | Sep 30, 2022 | Medical Device
A simple purchase decision for a regular use commodity is often influenced by the information printed on the product label. A Medical Device or Product is a high-risk commodity. For such products or devices labeling & packaging plays a crucial role in the final...
by Johari Digital | Sep 24, 2022 | Medical Device
Medical Device Development is a highly regulated task involving different talents including Engineering, Manufacturing, Designing, Regulatory& Quality, Sales & Marketing. Medical Device Contract Manufacturing unit needs the joint efforts of all these...
by Johari Digital | Sep 8, 2022 | Engineering, Medical Device
Medical Device Development is a highly regulated task involving multiple stages and different talents. The marketers in the MedTech firms are the first ones to interact with a new product idea. From day one when the discussion around a project begins to the time it...
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 | Aug 22, 2022 | Medical Device
Change is an essential part of the Medical Device Development Process. Every successful Medical Device starts from a naïve idea that undergoes very rigorous processing to come out as a successful medical device serving an exact purpose. A Medical Device Development...
