13 Nov

Essential Guide to Clinical Evidence for Medical Devices in the EU

Explore Key Standards and Guidance Documents

Posted at 13:52h in Medical Device & IVD Resources

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 provides...

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09 Oct

What is UDI (Unique Device Identification)?

Learn More About UDI Labelling for Medical Devices

Posted at 15:35h in Medical Device & IVD Resources

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,...

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08 Jun

Comprehensive Guide to Chemical Characterisation and Biocompatibility in Medical Devices

Understand Chemical Characterisation to Ensure a Safe and Compliant Medical Device

Posted at 16:03h in Medical Device & IVD Resources

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...

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22 Sep

A Guide to Data Sources and Literature Review During ISO 10993 Biological Evaluation

Watch Educo Life Science Trainer Rona Middlemiss

Posted at 09:28h in Medical Device & IVD Resources

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...

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30 Nov

Understanding ISO 10993: Navigating Biological Safety for Medical Devices

Explore the Standards Aims and Challenges

Posted at 07:29h in Medical Device & IVD Resources

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...

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21 Feb

Regulatory Affairs for Combination Products: Comprehensive Q&A

Q&A’s from the Free Module 1 Training Sessions

Posted at 17:02h in Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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...

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07 Jun

Understanding ISO 13485: A Guide for Medical Device Professionals

Learn more about ISO 13485 and how to successfully implement it

Posted at 18:02h in Medical Device & IVD Resources

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...

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14 Jun

Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices

Unlock the complexities of combination product development

Posted at 11:00h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

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...

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14 Jun

Medical Device Design & Development – Challenges When Transitioning Legacy Products

Interview with Educo Life Sciences expert Richard Young

Posted at 11:28h in Medical Device & IVD Resources

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 requirements...

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12 Jan

Can We Develop Products as Fast as the COVID Vaccines?

An Interview with Educo Life Sciences Trainer Nadine Ritter

Posted at 14:12h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

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 Fast as...

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13 Feb

How Will The IVDR Impact You?

Interview with Educo Life Sciences trainer Richard Young

Posted at 10:38h in Medical Device & IVD Resources

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...

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20 Jul

A Quick Guide to Internal Audits for Medical Devices and IVDs

Interview with Educo Life Sciences trainer Richard Young

Posted at 08:06h in Medical Device & IVD Resources

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 quality...

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24 May

A Short Guide to Human Factors in Medical Devices

Interview with Educo Life Sciences trainer Richard Young

Posted at 10:00h in Medical Device & IVD Resources

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 important...

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18 Aug

How to get a Medical Device on the Market

Discover the Regulatory Roadmap to CE Marking

Posted at 14:22h in Medical Device & IVD Resources

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...

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09 Sep

What is Medical Device Product and Process Validation?

Watch a short video guide with Educo Life Science Trainer Richard Young

Posted at 12:50h in Medical Device & IVD Resources

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 validation...

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22 Jun

A Short Guide to Software as a Medical Device

Watch Educo Life Science trainer Richard Young discuss the biggest challenges and common mistakes

Posted at 10:13h in Medical Device & IVD Resources

  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 device...

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06 May

A Comprehensive Guide to Medical Device Classification Under the MDR

From Class I to Class III Requirements with Examples

Posted at 10:28h in Medical Device & IVD Resources

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...

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11 Jul

What is a PRRC (Person Responsible for Regulatory Compliance)?

Learn More about the Role of a PRRC

Posted at 17:13h in Medical Device & IVD Resources

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...

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03 Feb

Medical Device & IVD Career Advice: Regulatory Affairs

An interview with Educo Life Sciences Trainers Anne Jury and Richard Young

Posted at 18:05h in Medical Device & IVD Resources

  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 that...

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