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pharma
Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and control...
On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.
Developing medical products is no easy feat. Most of these products are highly quality-sensitive and expensive. Naturally, most companies want to work with the best experts in the field, as there is little room for error. Consulting firms have steppe...
In the pharmaceutical and medical device 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 is the planning and organizing tha...
Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Pharma 4.0 is a framework for incorporating digital strategies into pharmaceutical manufacturing contexts. This framework envisions a manufacturing paradigm that allows manufacturers to change and iterate, connect resources and workers, simplify comp...
In the history of civilization and economic development, several industrial revolutions have brought about profound paradigm changes in society, economics, and culture, reshaping industries, creating new opportunities, and raising living standards fo...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.
medical devices
In the ever-evolving world of healthcare, Laboratory Developed Tests (LDTs) have emerged as critical tools for diagnosing a wide array of medical conditions. These tests, created and used by individual laboratories, are instrumental in everything fro...
Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates indepen...
In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality management system. Companies design and/or develop products every day to improve their existing produ...
You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing your medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regu...
The Internet of Medical Things (IoMT) is revolutionizing the MedTech industry by integrating medical devices, wearables, and health applications through Internet connectivity. This transformation enables continuous health monitoring, real-time data e...
Navigating the regulatory landscape is essential for medical device manufacturers aiming to market their products in Europe. As one of the most important regulatory markets in the world, the EU stands at the forefront of regulatory development and in...
Keeping track of medical devices is paramount to ensure the safety of patients. Traceability allows manufacturers to identify, trace, and control medical devices and is necessary for several reasons, chief among them regulatory compliance.
The prime directive of medical device manufacturers is the continued safety of patients through safe and effective medical devices. A critical aspect of medical device safety is ensuring regulatory compliance of any medical device destined for the co...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.
The world of medical devices is steeped in regulations - you can't say medical devices without saying compliance. In this world of medical device regulations, compliance is critical. It ensures the safety and efficacy of products entering the market ...
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compliance
When we observe the industry advancements, we see that software validation has become an indispensable yet challenging process. As regulations grow more stringent and technologies advance, the demand for smooth validation strategies is at an all-time...
Quality management software is gaining traction as a dependable adjunct to quality management teams. The benefits are substantial, especially in life sciences, where quality translates to rapport and, subsequently, sales. This growing reliance on qua...
The pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of drug products. As part of the FDA’s current good manufacturing practice (cGMP) regulations, 21 CFR Part 211 outlines stringent guidelines for drug manufact...
There’s a common misconception in life sciences that quality “costs” money — that any investment in quality such as an eQMS is just another financial burden. But that couldn’t be further from the truth.
A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.
Regulatory submission can bring both horror and delight to the office: it just depends on which stage you are at. Paperwork can be grueling yet equally rewarding when accepted. In the life sciences industry, regulatory paperwork is what gets your foo...
In the ever-evolving world of healthcare, Laboratory Developed Tests (LDTs) have emerged as critical tools for diagnosing a wide array of medical conditions. These tests, created and used by individual laboratories, are instrumental in everything fro...
In life sciences, one of the most heard terms is non-conformity management or NC management. To utilize and maintain an ideal NC management process, first, you need to understand what it is for and what are the risks and costs if it doesn’t work prop...
It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
quality management
When we observe the industry advancements, we see that software validation has become an indispensable yet challenging process. As regulations grow more stringent and technologies advance, the demand for smooth validation strategies is at an all-time...
A well-trained workforce is vital for the quality and safety of a product, particularly in the pharmaceutical industry, as well as other industries with strict regulatory requirements. Being “well-trained” means employees don’t just go through the mo...
The commercialization of medical devices and drugs depends on a single aspect – patient safety. Patients must know that the device or drug does what it is supposed to do and won’t unintentionally harm them. Enter, quality management. Quality manageme...
A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.
The right electronic Quality Management System (eQMS) can help strengthen your compliance processes and build a culture of quality within your organization. Discover the eight best quality management software and learn how to choose the right one for...
The modern medical life science industry is a multiple-wheeled machine. It takes a lot of groups working in tandem to get a medical product on the market. While the majority of the production and assembling might happen in the manufacturing facilitie...
As the life sciences industry becomes increasingly regulated and competitive, quality management has become more vital than ever. Are you confident in your organization’s Quality Management Maturity (QMM)?
Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates indepen...
In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality management system. Companies design and/or develop products every day to improve their existing produ...
On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.
