To begin with, we will first understand QMS. Quality Management system is a structured process and procedure which covers all aspects of designing, manufacturing, structuring, risk management, product labeling, clinical data, storage and more. This Article explains QMS perspective for drug device combination for a manufacturing company. Combination product regulated by FDA Guidance. Combination product means products which are combining drugs and devices such as pre-filled syringes, catheters with antimicrobial coatings, infusion pumps etc. ISO 13485 certification is mandatory and is globally accepted by different regulations. Whether you are looking to operate internationally or expand locally. ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities.
QMS perspective for drug device combination and challenges:
Regulations play crucial role for drug device combination as drugs are regulated by act 21CFR210/211 whereas medical devices are regulated by the act 21CFR 820, Human cells, tissues/Ps by 21 CFR1271 etc. For the commercialization of product, it is necessary for the organization to harmonize their product development with Quality management system. There is no clear explanation neither from MDR2017/745 nor from medical product directives for human use which can give a clear idea to reader about which requirement of MDR would or would not apply to device when combined with medical product.
Read More – QMS perspective for Drug device combination (operonstrategist.com)
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