The global hearing aids market is projected to be worth US$8,973.1 million in 2024. Through 2034, the market is expected to expand at a respectable 5.3% CAGR. By 2034, the market is expected to grow to a size of US$ 15,053.2 million.



As the number of people suffering from hearing impairments rises, hearing loss and other related issues are becoming more widespread. This makes wearing hearing aids necessary. The increased prevalence of hearing impairments and the increased use of… Continue

IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.

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IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) and resolve queries, if any, from USFDA.

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IZiel provides expert solutions to remediate FDA 483 observations and warning letters. IZiel team works with medical device companies across the globe to achieve regulatory and standard compliances. We take great pride in implementing best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries.

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