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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 etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

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 the importance of medical device registration. What are medical devices? Medical devices range from any instrument, medical software or medical equipment used by healthcare professionals. The medical industry can be

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 device classification. Regulating medical devices in the UK is essential, we can help you with how to complete the certification. In the UK, the Medicines and Healthcare Regulations Agency (MHRA)

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.

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. 

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. 

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

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