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If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA) requirements.

Most of the NIS2 Germany coverage I have read in the last six months came from law firms or IT consultancies. Much of it treats NIS2 as a standalone cybersecurity programme.

In highly regulated industries like pharma and biotech , organizations are typically well-versed in compliance and regulations. Yet as they scale, some quality systems begin to show cracks in ways that aren’t immediately obvious.

In the medical devices industry, “ design transfer ” refers to the process of transitioning a medical device from development to large-scale manufacturing. For manufacturers, particularly personnel in the quality, R&D, and manufacturing functions, a working knowledge of design transfer and compliance with requirements is essential. In this post, we’ll explain why design transfer is important, how…

In my experience as a quality professional, I have found that a CAPA medical device system is the most revealing part of a company's internal structure. I once worked with a team that had nearly 40 open files, some dating back eighteen months, because they treated the process as a secondary administrative task rather than a priority.

In 2026, the life sciences sector operates in a state of high-precision oversight, where even the most established partnerships require constant, data-driven verification. I recall a situation involving a critical component manufacturer who had maintained excellent performance scores for several years. During a scheduled supplier audit, we noticed a subtle but consistent trend in bioburden levels…

Most companies think quality is a cost. In reality, poor quality is the actual expense. In the pharmaceutical industry, poor quality comes with a significant and measurable cost . It can range between 15% and 40% of total sales revenue , as found by different studies . That means a significant portion of your company’s resources may already be lost to deviations, rework, batch failures, and ineff…

We’re wrapping up Q1 with a strong set of updates, bringing more speed, structure, and traceability across your quality processes.

The temptation to think of EU MDR certification as a milestone is strong. Something you achieve, check off your list, and move on from. But in practice, it’s part of the ongoing lifecycle management of your device.

If you’re here, chances are you’re considering, or already actively searching for, a knowledgeable life sciences consultant to help pave the way for your organization’s future growth. Maybe you need support achieving ISO 13485 certification, obtaining your CE mark, or overcoming challenges with international market access for your medical device.

Pharma audits are not routine checks. They are moments of truth. Whether it’s an internal audit, a supplier audit, a customer audit, or a regulatory inspection, the question is always the same: Can you prove, with evidence, that your Quality Management System (QMS) -aka Pharmaceutical Quality System (PQS)- is under control?

Quality management systems (QMS) refer to the set of policies, procedures, processes, and resources that a company or organization puts in place to ensure that their products or services consistently meet or exceed customer requirements and expectations. A QMS is designed to help organizations achieve their quality objectives by documenting best practices, focusing on customer satisfaction, conti…

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulatory consequences. For this reason, GMP certification is an essential prerequisite to be in the life science industry. If you are working on building a…

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 acronym ocean! Until recently, the most important (and most confusing) abbreviations to understand were: DHF, DMR, DHR. These three abbreviations hav…

In the life sciences, compliance is everything, and two of the most critical regulations are Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP). While they share a common goal of ensuring medicines are safe and effective, they apply to very different parts of the supply chain. GMP focuses on how products are made, while GDP ensures they are stored and distributed correctly. B…

Companies in the life sciences continuously strive to adapt to new developments in our rapidly evolving modern world. Professionals in businesses like pharma, medical devices, and biotech know that in this digital age organizing processes and going paperless with an Electronic Quality Management System (eQMS) is a must to keep up, let alone get ahead. If you work in the pharmaceutical industry an…

In the pharmaceutical industry, manufacturers must make sure medicines and healthcare products are made correctly, stored safely, and delivered to the people who need them. Supply chain management in pharma industry involves planning and coordination to ensure that every step, from production to distribution—runs smoothly and efficiently. There are three basic aspects of pharmaceutical supply cha…

A foundational aspect of quality assurance in the life sciences industry is being able to trust the data collected during all lifecycle stages of a pharmaceutical or medical device product, from R&D and clinical development through commercialization, manufacturing, distribution, and beyond.

The path to continuous improvement is well within research, and it starts with Quality by Design (QbD): a process that elevates product quality as a result of comprehensive risk management strategies. This article will start by answering the key questions: What is Quality by Design? And, why is QbD important? Then, we will dive into the key principles and guidelines behind it to provide you with …

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in any indicated situation. Potentially the most daunting task of medical device development is the regulatory aspect. Ensuring regulatory compliance can …