Our Services
Clinical EvaluationReport
HealthX experts acknowledge a good clinical evaluation report and are able to judge the acceptability of the CER for the Notified Body or local authority. Our team has extensive experience in medical writing, data analysis and, as experienced writers of CERs, are able to support any medical manufacturer.
quality and regulatory affairs
We will develop customized regulatory strategies that leverage your existing registrations. You can use HealthX services as a flexible shell to support your short term or long term projects. It can be in the form of hands-on resources or in the form of RA/QA interim management: our Regulatory affairs experts fill in specific expertise that you do not (yet) have within your team.
clinical research
We support all of your pre-CE clinical studies and Post-Market Clinical Follow-up (PMCF) challenges. Together we will secure sufficient clinical evidence to satisfy the regulator.