Telling your clinical story – Executing clinical evaluation plans and reports to provide regulators with an easy-to-follow evaluation of if the product is safe and effective. May include executing clinical gap assessments driving remediation.

Clinical evidence road maps – Developing a plan to ensure your product has sufficient clinical evidence to demonstrate performance and safety or to support marketing claims. Includes executing PMCF Plan and Reports.

Tracking safety –  Developing a plan of how the device will be followed throughout its time on the EU market and executing the reports per regulations. Includes writing PSURs and performing post market literature searches.

Providing Guidance - EU MDR guidance regarding clinical justification of validation tests, clinical claims, document management, and more.

Schedule Creation - Assistance in establishing a schedule system so that you always know what is due when. Includes support in the management of deliverables and executing the schedule established.

Getting your team ready - With new procedures and templates, training sessions will ensure your team can execute compliant documents with ease.