Blog
What is Design Verification in ISO 13485 — and why it matters in MedTech
In medical device development, compliance isn’t just a regulatory hurdle — it's a critical safeguard for patient safety and product integrity. One of the foundational elements in ISO 13485:2016 is design and development verification (clause 7.3.6), a stage that...
What is a Notified Body Opinion and why should you care?
Under EU MDR Article 117, manufacturers of medicinal products with integral device components (like pre-filled pens, syringes, inhalers) must submit a Notified Body Opinion (NBOp) as part of their Marketing Authorisation Application (MAA) — unless the device part...
ISO 20069 – A Guide to Assessing Changes in Drug Delivery Systems
Introduction In the fast-evolving pharmaceutical landscape, ensuring the safety, efficacy, and reliability of drug delivery systems (DDS) is paramount. ISO 20069:2019 provides a structured approach for assessing and evaluating changes in these systems, helping...
Foreseeable Misuse in Medical Devices: A Pillar of Risk Management
Foreseeable Misuse in Medical Devices: A Pillar of Risk Management Medical devices are critical to healthcare, yet their safety can be compromised by more than just manufacturing defects. Foreseeable misuse—incorrect use that can be reasonably anticipated due to human...
Pharmacopoeial Guidance for Gene Therapy Development: Essential Monographs and Chapters
Gene therapies, (ATMPs), demand rigorous adherence to quality standards. Pharmacopoeial guidelines, particularly those from the European Pharmacopoeia (Ph. Eur.), provide a foundation for ensuring product safety, efficacy, and consistency. For manufacturers navigating...
Key Elements for Pen Development
In the fast-evolving world of medical devices, pen injectors play a pivotal role in ensuring accurate and efficient drug delivery. Drawing from the latest standards such as ISO 11608 series, here are the key elements critical to successful pen development:1. System...
State of the Art (SOTA) in Medical Devices: Key Insights and Regulatory Expectations under MDR 2017/745
As medical devices evolve, ensuring their safety, performance, and clinical benefits remain aligned with the latest scientific and regulatory standards is critical. The State of the Art (SOTA) is a cornerstone of Regulation (EU) 2017/745 (MDR), emphasizing the need...