Regulatory assessment
Product Release Readiness Assessment
Your product release is approaching. Is the evidence ready for this exact version?
Ahead of launch, having documentation is not enough. Each document needs to match the right product configuration, target market and intended release event. This assessment brings your reported requirements and evidence position into one structured view, so release-critical gaps can be addressed before the final internal decision.
Determine your product's regulatory release readiness, identify missing evidence and prioritize the actions needed before market launch.
€299.00 incl. VAT
One assessment case · 180 calendar days of active editing access from purchase · two substantive report snapshots, each as a German and an English PDF.
Your practical benefits
Keep the configuration in focus: Connect hardware, software/firmware, market and release date to the documents that matter.
Prepare the next actions: Prioritise follow-up work with owners and practical closure criteria.
A document may exist — and still be wrong for the product you are releasing
An EMC package may be missing, the assessment basis incomplete or a safety dossier attached to an older device revision. The difference matters. With a known or suitably qualified regulatory route as its starting point, the assessment connects that route to the evidence reported for the actual release configuration.
What you receive
A professional, configuration-specific readiness report with an actionable release position, evidence and gap overview, identified blockers and unresolved checks, and prioritised actions for engineering, quality and product management.
Two substantive report snapshots are provided for one case, each with a German and an English PDF. Retrieving an existing PDF does not create a new report snapshot.
How it works
- Describe the version, markets, release event and regulatory route basis.
- Record evidence status against the relevant objects and versions.
- Review release-readiness findings, address gaps and issue a second substantive report snapshot when appropriate.
Who it is for
Manufacturers, engineering and product managers, quality assurance, Regulatory Affairs and compliance teams preparing a launch, variant approval or controlled product change.
What the sample case shows
A new industrial control-unit version is almost ready — but two release-critical evidence gaps remain. In the fictional IV-240 / CFG-B2 case, the EMC package is missing, its assessment basis is incomplete and a safety dossier belongs to an earlier configuration. The report distinguishes two release blockers and three prioritised actions, each with ownership and a closure criterion. It demonstrates how targeted follow-up replaces an undifferentiated document checklist.
Good to know
The assessment starts from a known or appropriately qualified supported regulatory route. It assesses reported readiness and evidence status; it does not perform laboratory testing, certification, regulatory approval or automatic substantive verification of document contents.
The 180-day period covers active case editing and creating the included report snapshots. It does not promise continuous legal monitoring or determine data-deletion periods. The agreed retrieval entitlement applies to stored reports.
Frequently asked questions
Our product has already been tested. Why assess it again?
Evidence must still be current and applicable to the exact version, market and intended release event. This assessment helps structure that check and the remaining work.
Does the tool read and validate every document?
No. It evaluates reported evidence status and the associated release requirements; full substantive document validation is not included.
Can the report be updated after we complete evidence?
Yes. The one-case product model provides a second substantive report snapshot for updated case information.
Related decision perspectives
Optional: free EU Market Check for a product
EU Market Access Assessment
Identify applicable EU product regulations, required compliance evidence and the next steps to bring your product to the EU market.
Supplier Regulatory Evidence Assessment
Evaluate supplier documentation readiness, identify missing regulatory evidence and define clear requests and corrective actions.