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What exactly is a technical file, and what information should it have?
What is a technical file for a medical device? A medical device technical file is a concise report created by a manufacturer to explain the
EUDAMED: Enhancing Transparency and Safety in Medical Device Regulation
In today’s rapidly evolving healthcare landscape, ensuring the safety and effectiveness of medical devices is of paramount importance. To address this, the European Union (EU)
A road map for the clinical evaluation strategy is the clinical evaluation plan (CEP).
A vital starting point and manual for the clinical evaluation of your medical device is the Clinical Evaluation Plan, or CEP. Find out more about
Quality Assurance & Quality Control
Quality assurance (QA) and quality control (QC) are two important concepts in the medical device industry. Although they are related, there are distinct differences between
Medical device & IVD registration
Commercialising your medical device or IVD first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell
Medical Device Startups – is not applying a regulatory strategy early on costing them more in the long run?
Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital
Medical Device Design and Development
Here we will try and explain the processes involved from a Regulatory and Quality Assurance perspective of what is involved in the design and development
What is ISO 13485?
Medical devices must be of high quality to be considered safe on the market. Strict safety and quality regulations must be met to achieve this.
What is the importance of medical device registration?
Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at
Regulating medical devices in the UK
Ensuring the safety of medical devices before they enter the market is very important. There are various regulations that must be followed based on the
Person Responsible for Regulatory Compliance (PRRC) MDR
This blog will explain the Person Responsible for Regulatory Compliance (PRRC) MDR service and the necessary steps to ensure that your medical device is compliant
ISO 13485 Requirements Quality Management System
ISO 13485 requirements guide for: Medical Devices – Quality Management Systems – Requirements for regulatory purposes Introduction ISO 13485 can be used by organisations that
Medical Device Classification EU
This blog explains the Medical Device Classification in the EU and what medical devices belong in which relevant class. The European Union (EU) device classification
Medical Devices Classification UK
This blog talks about Medical Devices Classification in the UK. A Medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article
Quality Assurance vs Quality Control
Quality Assurance (QA) vs Quality Control (QC) is a commonly asked question but both are important aspects of Quality Management Systems (QMS). They work side
Top 5 quality management system failures
In this blog, we will discuss some of the (in our opinion) top 5 quality management system-related failures. These failures had massive consequences, including loss
UK Medical Device Requirements
The United Kingdom left the European Union on the final day of December 2020, this was before the Medical Device Regulations EU 2017/745, and In
IVD Directive Essential Requirements Checklist
The 8 Step Essential Requirement checklist for IVD Directive. The IVDR EU 2017/746 is responsible for governing the regulatory market access for in vitro diagnostic
The Benefits of ISO 9001 Quality Management System
The quality management system ISO 9001 is a set of international standards to ensure efficiency and productivity in an organisation. It is known as the
