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.
More articles from Damla Varol
In the life sciences industry, the concept of quality transcends mere compliance and enters the domain of strategic business importance. The cost of quality, a pivotal communication tool, was profoundly emphasized by Philip Crosby, a titan in the qua...
Life science industries have their language and it consists of many concepts, terms, and abbreviations that are commonly mixed up. When you see them together it is even harder to grasp the nuances between concepts. Today we’ll give you a long list of...
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...
Managing your documents doesn’t have to feel like a never-ending nightmare. Good Documentation Practices, also known as GDP or GDocP, are essential to streamlining your document workflow, enhancing employee efficiency, and ensuring compliance with re...
Did you know that 80% of Life Sciences companies are lagging behind in digitalizing their core business? For some, paper documentation is still piling up. For others, their new digital solutions are not yet fully utilized.
Creating a culture of quality is paramount to success, especially in the fiercely competitive pharma and medical device industries. Having a strong quality culture allows you to spark innovation, foster seamless teamwork, and ensure compliance with r...
GMP stands for “Good Manufacturing Practices.” In life sciences manufacturing, a buzzword you'll often hear is "Good Manufacturing Practices," commonly known as GMP. But what exactly does it entail? This piece will outline the five main components of...
While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...
Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why quality professionals in the pharma industry actively seek to understand cGMP compliance. In most cases, they also learn on the go...
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...
The requirements of life sciences companies (including in the pharma and medical device space) inevitably change over time. Sometimes, a change is due to regulatory requirements; sometimes, customer needs change. Keep reading if you want to learn mor...
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...
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