To Strive. To Seek. To Find.

Evnia introduces a paradigm shift in the MedTech/BioTech consulting services by offering expert medical device lifecycle management services.

We support manufacturers throughout the medical device development roadmap. From the early concept and design stages to verification and validation, until market access and post-market adulthood, Evnia enables compliance and ensures audit and inspection readiness.

At Evnia, we serve MedTech and BioTech companies of all sizes, including Billion+, Midsize, and Startups, while remaining flexible to the needs and integration each one of our partners requires.

From building long-term partnerships to developing regulatory and clinical strategies, Evnia recognises each medical product’s unique needs and offers customised services that are adding clinical and commercial value to your portfolio. We shorten your time until market access and we support your day-to-day business pre- and post- market.

Using industry knowledge, proprietary tools, and streamlined processes, we help you turn challenges into opportunities.

Don’t know how to turn the sketch on your napkin into a successful medical product? Contact Evnia today and take your idea to the international markets faster, with less risk making patient impact.

Device Lifecycle Management Services

Authorised Representative

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).

UK Responsible Person

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).

Real Word Evidence (RWE)

PMCF Surveys

Registries

Clinical Experience Data

Evnia Clinical Network

Meet EVA

Our automated vigilance algorithm that scans, analyses and report several incidents from multiple vigilance databases on real time.

Clinical Evaluation Reports

We have refined our clinical evaluation process to ensure a comprehensive assessment of the device’s safety and performance profile with proven audit success.

PMCF Planning

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.

Real Word Evidence (RWE)

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.

Technical Documentation

We provide a full spectrum of services to cover key areas of technical & clinical documentation, such as:

Usability engineering

Risk management

Procedure & benefit risk analysis

Validation and more!

Regulatory Affairs Management

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.

In Vitro Diagnostic Regulation (IVDR)

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.