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lidia356

Lidia

@lidia356

Business Specialist

United Kingdom
English, Spanish, French, German
About me
With over a decade of expertise, I offer specialized medical device regulatory services, ISO documentation, and compliance. As an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016, I ensure top tier standards. Proficient in navigating MDR 2017/745, MDD, FDA, cGMP, and ISO standards, I provide tailored compliance strategies, including technical writing and global regulatory affairs. My expertise extends to HSE plans and SFDA documentation, making me a reliable partner for sustained success. #MedicalDevices #ISO ... Read more

Skills

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lidia356
Lidia
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Certifications & Regulations
I will provide iso 13485 medical device compliance, quality management system