At Evnia, we enable manufacturers that develop medical and in-vitro diagnostics devices worldwide to remain in compliance with regulatory standards in clinical, IVD, and technical documentation requirements to ensure their audit and inspection readiness.
An EU Authorised Representative (EU AR) needs to be designated by all medical device or in vitro diagnostic manufacturers based outside the EU that wish to sell their products in any of the Member States (MDR/IVDR Article 11).
According to the UK Medical Devices Regulation 2002 (SI 2002 No.618, as amended), all medical device and in vitro diagnostic (IVD) manufacturers located outside the UK that want to place a medical device (or IVD) on the Great Britain market (England, Wales and Scotland) are required to appoint a UK responsible person (UKRP).
Our automated vigilance algorithm that scans, analyses and report several incidents from multiple vigilance databases on real time.
We have refined our clinical evaluation process to ensure a comprehensive assessment of the device’s safety and performance profile with proven audit success.
Post Market Clinical Follow (PMCF) up is a continuous process, mandated by Medical Device Regulation. The regulation specifies the manufacturers responsibility to proactively collect and evaluate clinical data with the aim of confirming the safety and performance of the device throughout its expected lifetime.
We provide a cluster of services related to the generation of real-world evidence (RWE) assisting manufacturers to support their clinical development strategy throughout the entire lifetime of medical devices. Development of registries, collection of clinical experience data, conduct of surveys, either stand-alone or in combination, become an efficient tool for the establishment and confirmation of clinical safety and performance especially in the PMCF setting.
We provide a full spectrum of services to cover key areas of technical & clinical documentation, such as:
We provide project management and interim management services for Medical Device and Pharma organisations to help ensure a holistic approach to the needs and unique business requirements of your organisation.
We provide help and guidance in preparing your performance evaluation plan and reports to ensure that your in-vitro diagnostic medical device is in full compliance under IVDR.
We are here to assist. Contact us by phone, email or via our Social Media channels (Twitter or LinkedIn).
