Ontogen Medtech collaborates with mHUB as supporting industry partner for Medtech Accelerator cohort

Differences Between MDD and MDR in Medical Device Regulation

In the European Union (EU), the regulation of medical devices has undergone a significant transformation with the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). This shift aims to enhance the safety, performance, and traceability of medical devices within the EU market. Understanding the key differences between MDD and MDR is crucial for manufacturers, regulatory professionals, and other stakeholders in the medical device industry. This blog post explores these differences, emphasizing how they impact the development, approval, and post-market surveillance of medical devices.

30 Medical Device Acronyms You Should Know

Navigating the medical device industry involves understanding a plethora of acronyms and specialized terms. Here’s a comprehensive guide to 30 key acronyms and terms that are crucial for professionals in this field. Each entry includes a brief explanation to help you grasp their importance and application.

What is Document Control and why is it necessary?

Document control for medical devices is the process of managing and maintaining the documents related to the design, development, production, and use of a medical device. This includes creating, reviewing, approving, distributing, and archiving documents such as specifications, test plans, and user manuals. The purpose of document control is to ensure that the correct version of a document is being used, that the information in the document is accurate and up-to-date, and that the document is readily accessible to those who need it. It also helps to ensure compliance with regulatory requirements for medical devices.

Understanding Software as a Medical Device (SaMD)

In the rapidly evolving field of medical technology, Software as a Medical Device (SaMD) has emerged as a significant and transformative category. SaMD refers to software intended for medical purposes that perform these purposes without being part of a hardware medical device. The rise of digital health and advanced computing capabilities has expanded the potential applications and importance of SaMD. This blog post will explore what SaMD is, its regulatory framework, benefits, challenges, and future trends.

Cybersecurity for Medical Devices: an Overview