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.

More articles from Damla Varol

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 the details of cGMP regulations. In most cases, they also...

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...

9 min read.

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...

Internal audits can strengthen the quality management system (QMS) of your organization by improving sub-processes by identifying open issues and opportunities. In addition, internal audits can be more informal than external audits so that your organ...

How much do you know about Medical Device Coordination Group Documents? You may be more familiar with their abbreviation: MDCG. Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medic...

In the medical device industry, there are tons of abbreviations. And as a medical device professional you can easily get lost in this acronym ocean! The most important (and most confusing) abbreviations are DHF, DMR, and DHR. These three abbreviation...

Artificial intelligence (AI) and machine learning (ML) are on the verge of transforming healthcare by creating new, vital insights from the vast amount of data gathered during healthcare delivery activities every day. AI/ML-based life science innovat...

To successfully get a drug FDA approved, the data on the drug’s effects need to be reviewed by the Center for Drug Evaluation and Research (CDER), which in turn needs to determine that the drug’s benefits notably outweigh its known and potential risk...

The final date for all MDD-certified devices to be certified under the new MDR is May 25, 2024. Once a medical device is EU MDR compliant (even prior to this date), it can be certified under the MDR. However, it is not mandatory to obtain EU MDR cert...

The skills matrix as an HR and project management tool The skills matrix is one of the core management tools to ensure your success in every project as an employee, as a team, or as a data-driven HR professional. A skills matrix – also known as a com...

Introduction to Audits An audit is the verification, inspection, or examination of a process, product, or system to guarantee compliance with regulatory or organizational requirements. The scope of an audit can apply to an entire organization or be l...

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