<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=489233&amp;fmt=gif">
Damla Varol

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.

5 min read.

2025 is almost over. Oh, how time flies! As we are entering the last quarter of the year, there are still plenty of conferences and trade shows for you to attend. These events are a great way to stay on top of today’s rapid and sometimes overwhelming...

Like any other regulated product, your medical device must be properly labeled. But do you know how to prepare a medical device label and which regulations your label has to comply with? And how about which ISO standards can help you meet these regul...

In addition to meeting rigorous safety requirements, medical device manufacturers must also comply with strict quality standards. That is why a compliant Quality Management System (QMS) is fundamental to any Life Sciences company operating in the tig...

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 ...

The medical device lifecycle is an inherently complex process with increasingly rigid requirements that must be met for FDA approval (21 CFR Part 820) and/or EU MDR compliance.

Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...

Subscribe to the

Scilife Blog

Life Science and Quality resources and news. All directly to your inbox!

Scilife Skyrocket microscope | Scilife