Sensus appreciates that the need to initiate these changes is immediate and overwhelming.

We are able to source and provide the experts, teams and resources required to ensure your company is able to meet the new regulations. We can provide the workforce that will be able to manage the additional hours, understand the regulations and facilitate the implementation. We can also train your existing staff, leaving you with full peace of mind that you will be compliant with the new regulations.

Your complete portfolio of products will need to be reviewed and assessed against the new regulations, i.e. under the new directive, anything that is classified as an accessory could now be covered under the definition of a medical device. Some of your products may need reclassification or clarification of future status.

We can ensure that all gap analysis and potential areas for consideration are dealt with and documented.  We would then produce an implementation project plan outlining timelines and costs and if necessary any additional training provided for further products.

Some of the most critical key areas that will need assessment are:

Clinical Evidence

Risk Management

Quality Systems

General Safety and Performance Requirements

Device identification / Labelling

Human Factors Engineering

Third Party Supply chain

Post Market Surveillance and PMCF

Distributor Networks

Verification and Validation Tests