RegToDate is the service created by Thema to help and support Manufacturers who need to stay up-to-date on legislative, regulatory and normative changes that characterise the medical device and IVD sector at national, European and international level.
Researching, analysing and selecting laws, standards and regulations is particularly challenging for manufacturers because it requires a lot of time and skilled resources, it must be performed on a recurring and ongoing basis and depends on the type of product and processes involved.
With the RegToDate service, Thema:
- carries out the research, analysis and selection of measures on behalf of the manufacturer;
- develops the activity in a customised manner, taking into account the product and the organisation;
- carries out the activity in a comprehensive manner;
- updates the list of documents of external origin;
- proactively carries out the periodic update activity.
The service is divided into two steps: The initial update and Maintenance.
The initial update includes a BASIC formula and a SPECIAL formula. The first includes checking the status of the technical standards in the customer list, checking for new versions and updating the standards in the same list, without adding new items. The second includes, in addition to the basic service, the integration with other measures such as applicable laws and guidelines.
Maintenance can only be carried out after the first step has been completed and requires the definition of an update frequency with the manufacturer. This step consists of checking the status of the laws, standards and guidelines in the customer list, checking if there are new revisions and updating those in the customer list, without adding new items.