Understanding Software Medical Devices: Navigating the EU Regulations and Clinical Evaluations
Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
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CE approval for Medical Devices under MDR: key requirements for your device class
Explore the crucial steps for obtaining CE approval for your medical device under MDR. Learn more about the key aspects of conformity assessment tailored to each device class.
Qualifying a New GMP Facility: From Pitfalls to Best Practices
On the path to qualifying a new GMP facility? Learn about frequent pitfalls and the best practices we recommend to handle them.
Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects
Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory requirements. Learn more about QbD Group’s Project Management Process here.
Importing medicinal products into the EU? A Brief Guide to EU GMP Compliance.
Are you a medicinal product manufacturer looking to import into the EU in line with EU-GMP import regulations? Be sure to read this article.
Status of the medical device regulatory landscape: An interview between QBD Group and Irdeto
On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regulatory landscape. Read the interview here.
Computer Software Assurance (CSA) in Pharma Industry: First Steps to move from CSV to CSA
In this blog post, we explore Computer Software Assurance (CSA), a modern alternative to traditional Computer System Validation (CSV), focusing on its crucial role in the pharmaceutical industry. Discover the key differences between CSA and CSV, the initial steps for transitioning from CSV to CSA, and why the CSA approach is increasingly important for ensuring system reliability, security, and compliance in drug development and manufacturing.
Understanding plasmids: small molecules with big implications
Explore the essentials of plasmid manufacturing and regulations for applications like gene therapy and vaccine development.
Oncolytic viruses: the use for cancer immunotherapy
Oncolytic viruses and cellular immunotherapy are creating significant new potential in the fight against cancer. Learn more about the working mechanism, risks, and specific biosafety requirements to be considered for oncolytic viruses.
Paperless Validation in Pharma: embrace the future
Discover the future of pharma: enhancing efficiency and cutting costs with paperless validation. Learn how to navigate the path to agility and innovation in the digital era.
GMP-compliant design of climate or stability chambers: the key to ensuring product integrity
In this blog post, we delve into the world of GMP-compliant design for climate chambers, unraveling the vital role they play in the stability testing of pharmaceutical products.
Regulatory guidelines for stability testing: a brief overview
In this blog post, we address key regulatory guidelines for stability testing to ensure high-quality products meet regulatory requirements and patient needs.
State Of The Art Literature Review – Process and Documentation
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
4 Factors Influencing the Stability of Medicinal Products
In this blog post, we will explore the various factors that influence the stability of medicinal products and the parameters that need to be considered during their storage.
The digital health revolution in pharma
AI, machine learning, blockchain, big data, and other buzzword technologies are making inroads into the biopharmaceutical sector, improving quality, traceability, and efficiency. Read more about how digital health is changing pharma here.
Mastering Cleanroom Qualification: navigating the latest regulatory updates
Discover the latest key changes in cleanroom qualification regulations, exploring the impact of the different test phases (qualification, classification, requalification, monitoring) with a focus on risk assessment.
Computerized System Validation in clinical trials: key considerations
Discover the importance of software validation in clinical trials. Learn how it applies to GCP and GMP systems. Stay ahead in the digital era.
State of the Art (SOTA) Literature Review – What, Why, When, and Who?
In this blog post, we would like to share with you the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.
The Importance of Stability Testing in Pharmaceutical Development
In this blog post, we will delve deeper into the significance of stability testing in pharmaceutical development.
Pharma 4.0: The Future of Pharmaceutical Manufacturing
Discover how Pharma 4.0 is revolutionizing pharmaceutical manufacturing. Learn about the benefits, challenges and key components and how it improves efficiency, quality and patient safety.
Clinical Literature Review – Common Gaps and Hurdles to Take
In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).
EudraLex Volume 4 Annex 11: compliance checklist and future prospects
This article addresses the latest revision of EudraLex Volume 4 Annex 11 and provides a checklist for compliance. Download it now.
A Deep Dive into Clinical Trials Regulations: Shifts and Strategies in the UK and EU
The past couple of years have borne witness to pivotal shifts in clinical trial approvals within the UK and EU. With the UK implementing the Combine Review system and the EU transitioning from a previous Directive to the EU Clinical Trials Regulation, both regions are aiming for enhanced efficiency, streamlined processes, and heightened transparency. Learn more here.
The EU Commission Proposes a General Reform of Pharmaceutical Legislation – What it Means for Patients and the Industry
The EU Commission is proposing a general reform of pharmaceutical legislation. Read more about what this means for patients and the industry.
How to keep computerized systems in the operational phase?
Maintaining computerized systems during the operational phase is critical to the proper functioning of organizations. In this article, we explore some of the best practices for doing so.
Types of Medical Writing: Introduction to the Art of Medical Writing in Healthcare
Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
Automated software testing for the GxP world
Struggling with CSV validation and testing automation? Tired of re-validating at every sprint? Discover expert tips to reduce time, and budget, and increase validation coverage in our latest blog post on automated software testing for the GxP world.
Analytical Method Validation: are your analytical methods suitable for intended use?
In this blog post, you will learn more about analytical method validation and the criteria to consider when validating your analytical method.
MDR transition: how to plan MDR compliance for your Medical Device?
Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
ILAP: Introduction to the UK’s Innovative Licensing and Access Pathway
The UK government introduced the Innovative Licensing and Access Pathway (ILAP) in 2021 to give patients quicker access to cutting-edge treatments and therapies by offering a streamlined approach to licensing and regulatory processes. Learn more about ILAP in this blog post.
MHRA GMDP Symposium: key insights, trends, and best practices
QbD Group Ltd. attended the MHRA GMDP symposium, a highly anticipated annual event that brings together stakeholders in the pharmaceutical industry to discuss the latest trends and developments. Discover our insights here.
What is the Agile model in Computerized System Validation?
Want to introduce robustness into your software validation activities? In this article, you will learn what the Agile model is and how to use the GAMP 5 framework for agile development.
EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products – Summary and first insights
The EU GMP Annex 1 Manufacture of Sterile Medicinal Products was revised in 2022. In this blog post, we will provide a summary of the changes and our initial insights several months after the revision.
MDR Annex XVI: products with non-medical purpose — Compliance and Common Specifications (CS)
Annex XVI of the MDR EU 2017/745 lists products without an intended medical purpose that now fall under the MDR. In this blog post, you will learn more about the contents and requirements of the annex.
UK’s medicines regulator announces IT roadmap
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is developing a new IT system to streamline submissions related to product licensing and process licensing. The first release of the system is expected by the end of 2023, with subsequent releases incorporating wider elements such as medical devices and import notifications. An agile delivery model will enable continuous improvement based on user feedback.
7 key areas to focus on during internal or supplier audits
Regulatory agencies impose internal audits and supplier audits in the pharmaceutical and medical device industries to ensure compliance with Good Manufacturing Practices and ISO standard requirements. These audits help identify potential problems that may affect product quality, efficacy or safety, and provide a mechanism for implementing corrective actions to minimize public health risks. In this blog post, we’ll discuss 7 key areas to focus on during internal or supplier audits.
8 steps to successfully respond to non-conformities in an inspection report
Learn 8 logical steps to take prompt action when national competent authority inspection reports, EIRs, FDA Forms 483 or warning letters show non-conformities. Failure to act can have crippling consequences.
Celebrating International Women’s Day with power lady Elly De Bruyn, CHRO at the QbD Group
In celebration of International Women’s Day, we sat down with Elly De Bruyn, Chief Human Resources Officer (CHRO) at the QbD Group, to talk about her experiences and views as a power lady in the life sciences industry.
Introduction to Digital Health in Clinical Trials
Learn how digital health is transforming clinical trials. Explore the benefits and challenges of implementing digital technologies.
What is the GAMP 5 V-model in Computerized System Validation?
Want to introduce robustness into your software validation activities? In this article, you will learn what the GAMP 5 V-model is and the key steps within it.
Essential Documents in Clinical Investigations with Medical Devices: a brief overview
This blog post provides an overview of essential documents required during medical device clinical investigations in accordance with ISO14155:2020.
The European Parliament adopts proposed amendment to Medical Devices Regulation 2017/745 (MDR) to extend transitional deadlines for legacy Medical Devices
The European Parliament has approved a proposal to extend the transitional deadlines for certain medical devices under the MDR to ensure availability of devices whose certificates have expired or will expire before 26 May 2024. Manufacturers must adhere to specific conditions to comply with the new transition periods. Learn more here.
Qualification of laboratory equipment: key considerations and challenges
Are you about to qualify your laboratory equipment? If so, here are the key considerations and challenges to consider.
UDI for software: how to mark your MDSW with a UDI?
Each individual medical device must have a Unique Device Identifier (UDI) with its carrier (barcode or QR code). But what about medical device software? Read the answer in this article!
Are systems in compliance with ISO 80002-2 if we follow the guidelines described in GAMP5?
Can the computerized system validation used in pharma be applied to non-product medical device software? In this article, we compare ISO 80002-2 with GAMP5 to find out.
Medical Device and IVD industry trends for 2023
In 2023, the IVD industry will continue to dominate the medical technology market due to rising demand for early diagnosis, treatment and point-of-care testing. Product trends include the accelerated consumerization of diagnostics, the rise of telemedicine and digital health, the growth of devices enabling personalized medicine and the emergence of AI and robotics-powered medical devices. Medical device manufacturing will undergo changes in the computerized system validation process due to the increased focus on critical thinking by GAMP5 and FDA.
Change Control Management: how to keep your systems compliant?
In this article, you will learn a structured approach to ensure regulatory compliance and proper operation of your computer systems, throughout their life cycle.
Helping others is what brings the QbD Group joy every day
December is often symbolized as the ‘Month of Giving’ as it revolves around giving something back to society, helping others and spreading joy. Supporting good causes is one way we put our company value ‘joy’ into practice at the QbD Group. Let’s highlight a few of them!
The Advent of Artificial Intelligence and Machine Learning in Medical Devices
Artificial intelligence (AI) and machine learning (ML) are on the rise in the medical device and IVD industry. Learn more about the current landscape and regulatory framework here.
Annual Product Quality Review (APQR) in Pharma: importance, benefits & challenges
Learn more about the importance, benefits, and key challenges related to Annual Product Quality Review in Pharma.
5 tips to score a job as a Life Science consultant
Job fair season is upon us! Whether you’re looking for your first job or a new work adventure, we can all agree that applying for a job comes with a healthy dose of nerves. To make sure you are the best version of yourself, preparation is key! Want to succeed in your next interview and land your QbDream job in consulting? Put your foot in the door and kick it wide open with these 5 tips!
Medical Device development: the importance of Design Transfer and Process Validation
Bringing a Medical Device to market involves many hurdles, including design and development. In this blog post, you will learn more about the importance of Design Transfer and Process Validation in medical device development.
QbD Group awarded Baanbrekende Werkgever ’23 certificate for the second year in a row
Today, on Nov. 14, 2022, we proudly received the Baanbrekende Werkgever ’23 certificate for the second year in a row, representing our commitment to put our employees at the center of our policies around hybrid work and mobility.
What is digital health? Exploring the landscape and future opportunities.
Digital health is on the rise, but what is digital health exactly? In this blog post, we’ll explore the landscape, key technology pillars and future opportunities.