The UKCA certification mark is a UK product marking used for goods being placed on the market in Great Britain (England, Scotland, and Wales). It signifies that a product complies with UK regulatory requirements, which may differ from those of the Europea...

The regulatory landscape for Medical Device Consultants in the United Kingdom has undergone significant changes, especially post-Brexit. One of the critical requirements for non-UK manufacturers wishing to place their products on the UK market is the appo...

The regulatory landscape for Medical Device Consultants in the United Kingdom has undergone significant changes, especially post-Brexit. One of the critical requirements for non-UK manufacturers wishing to place their products on the UK market is the appo...

A CE marking consultant has extensive knowledge of the CE marking process and the relevant EU directives and regulations. They can provide you with guidance and advice on how to ensure that your product meets the necessary requirements.

Manufacturers must have their product assessed by a notified body that has been granted approval by an EU Member State. Notified bodies assess whether or not products comply with MDR and other relevant EU legislation (e.g., electrical safety, electromagne...

When it comes to medical devices, it's important to comply with regulations set forth by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Here are some key points to keep in mind when it comes to MHRA registration for medical devi...