The main reason medical device registration is so important is safety. Ensuring that devices meet medical device regulations means that everyone involved can be confident that they are safe for their intended use. All medical devices are extremely important and can have life-saving capabilities. This means that devices must be working to their full potential.
What is the importance of medical device registration? Read More »
When manufacturing medical devices for the UK market, you must be registered with the MHRA. They can help to ensure that your device meets safety guidelines and issue you with advice should you need it.
Regulating medical devices in the UK Read More »
Part of these new measures is the introduction of a Person Responsible for Regulatory Compliance (PRRC). Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), the legal requirements for the PRRC are presented.
They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.
Person Responsible for Regulatory Compliance (PRRC) Read More »
The ISO 13485 standard was built around the structure of ISO 9001 which is a standard for Quality Management Systems Requirements applied across all industry settings other than medical device companies.
ISO 13485 – Quality Management System Read More »
In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market.
Medical Device Classification EU Read More »
In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.
Medical Devices Classification UK Read More »
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 by side but the two are defined differently. It is common for these two terms to be used interchangeably, however, there are distinctive differences between the two. QA manages the
Quality Assurance vs Quality Control Read More »
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 of life and financial impact, for the companies and organisations involved. Hopefully, by the end of the blog, you should also have a good understanding of why having a quality
Top 5 quality management system failures Read More »
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 (IVDR) medical devices. It also includes the requirements for each device’s technical documentation. The information can vary based on the classification of the device, but it is always the main piece of evidence within the essential requirements.
IVD Directive Essential Requirements Checklist Read More »
Implementing quality management system (QMS) iso 13485 couldn’t be easier with our step by step guide. A quality management system is necessary in medical compliance. A QMS is simply a set of tools, processes or procedures put in place to offer high quality. The most recent version of the iso 13485 QMS dates back to
A guide to ISO 13485 Read More »
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
