Damla Varol
QA Consultant, Scilife
With 14+ years of experience in medical device and pharmaceutical manufacturing, Damla is a QA RA Consultant known for her meticulous attention to detail and passion for quality standards. From working with the largest manufacturing companies to medical device start-ups, she has mastered ISO 9001, ISO 13485, MDD, MDR, and FDA CFR 21 Part 820 regulations. Applying her extensive expertise and skills, she offers practical compliance solutions and invaluable insights to help industry professionals achieve compliance excellence.
Most pharmaceutical and medical device companies adopt an electronic Quality Management System (eQMS) to centralize and control quality processes, improve traceability, and support compliance with applicable regulatory frameworks, including ISO 13485...
In the medical device industry, there are tons of abbreviations. And as a medical device professional in the US working with Quality Management Systems Regulations (QMSR), or 21 CFR Part 820 as it’s technically known, you can easily get lost in this ...
Companies in the life sciences industry need to deal with stacks and stacks of documents. Whether they’re paper or digital, chaos is inevitable if documents are not kept meticulously organized. Document control software is frequently used in the life...
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