Person Responsible for Regulatory Compliance Training | PRRC Training

Many of our medical device and IVD training courses offer a free-to-attend Module 1, giving you valuable insights and a preview of the full course experience. Browse the available courses below and register using the form provided. Once registered, you'll receive joining instructions for the...

Introduction: The Role of Clinical Evidence in Medical Device Compliance In the European Union, gathering clinical evidence for medical devices is essential to regulatory compliance, particularly under the Medical Device Regulation (MDR). Clinical evidence helps demonstrate that a device is safe, performs as intended, and…

Navigating the U.S. Food and Drug Administration (FDA) regulatory process can be one of the most challenging steps for medical device manufacturers aiming to enter the American market. Unlike the European system, where the CE marking process is guided by Notified Bodies under the Medical...

Artificial intelligence is no longer a future-facing concept in medical technology — it is already embedded in diagnostic imaging, clinical decision support, digital pathology, wearable monitoring systems and predictive modelling tools. However, as AI capability has accelerated, so too has regulatory scrutiny. The introduction of...

The Unique Device Identification (UDI) system is a globally recognised framework designed to provide a unique identifier for medical devices, enhancing traceability and safety within healthcare. It has become a cornerstone of regulatory efforts in both the United States and Europe, ensuring that medical devices,…

In the medical device industry, ensuring safety and compliance with regulatory standards is paramount. Chemical characterisation and biocompatibility testing are essential steps in this process, guided by frameworks such as ISO 10993. These evaluations help manufacturers understand the materials in their devices and assess potential…

We interviewed Educo Life Sciences trainer Rona Middlemiss to discuss Biological Evaluation literature review and data sources. This area is critical as it is a requirement of all medical device categories as per ISO 10993. It aims are to assess the risk and benefits of…

ISO 10993 is the cornerstone standard for assessing the biological safety of medical devices. By focusing on risk assessment rather than prescriptive testing, it provides a flexible framework for evaluating device materials in their final form. This guide delves into the scope, challenges, updates, and…

Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly...

ISO 13485 is a critical standard for companies involved in the design, development, and production of medical devices. It provides a framework for implementing a quality management system (QMS) specifically tailored for the unique regulatory requirements of this sector. In this article, we will delve…

Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and…

Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations. The new European Medical Device Regulations means that legacy products need to meet new…

We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of a drug in history.   Why Can’t We Develop Products as…

The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Under the Directive, most IVD products were self-certified. The IVDR is going to change all that with a new risk based classification system, many now need notified bodies…

At Educo Life Sciences we have seen a recent increase in training requests/deliveries around internal audits for both devices and IVDs. As the regulatory landscape shifts to the MDR and IVDR, companies may be increasing their activities to demonstrate compliance. We interviewed our regulatory and…

The main aims of Human Factors Engineering (HFE) or usability are to create safe and effective medical devices and IVDs for human use. It is concerned with the design of devices that considers human capabilities, limitations, and characteristics. HFE in medical devices has become more…

Bringing a medical device to market is a complex and multifaceted process that requires careful planning, extensive documentation, and adherence to stringent regulatory standards. In this guide, we will break down the essential steps for obtaining CE or UK CA marking, discuss the importance of…

Product and process validation is critical process that must be done for regulatory compliance to ensure patients safety. Its main aim is to make certain the product is made correctly and consistently. We interviewed Educo Life Sciences trainer Richard Young to discuss product and process…

  If you have a piece of software as part of your device you must be aware of the regulatory requirements in place to maintain patient safety. Whether it is an app that provides some additional features or specialised software that is critical to the…

With the introduction of the new Medical Device Regulation (MDR) in Europe, the classification of medical devices has become more structured, emphasising the importance of patient safety at every risk level. From low-risk products in Class I to high-risk Class III devices, each category comes…

The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role introduced by the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) under Article 15. As of 2017, all manufacturers, regardless of size, are required to appoint a PRRC to ensure…

  We interviewed two of our trainers to get their views on a career in medical devices & IVDs, specifically regulatory affairs. They share their career experiences and provide some advice for those at different points in their device career. They discuss the many reasons...