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A Medical Device Consultancy Focused On
Vision, Product And People.

INDUSTRY EXPERTS SUPPORTING YOU THROUGH GROWTH AND CHANGE

who we are

Who We Are

Arevna Consultancy is a Solutions provider with over 20 years’ experience specialising in Quality and Regulatory Compliance for small, medium and large-scale Medical Device manufacturers. We create solutions for clients who require a dedicated Medical device Consultancy with its own network of Subject Matter Experts.

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Our Mission

Our mission is to understand Client requirements and provide unique tailor-made solutions. Employing industry Subject Matter Expert’s (SME) we will find solutions for you that work with your budget and timeframes. We aim to be the first port of call for all our clients for any Regulatory and Quality needs.

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Our Vision

To be the market leading partner of choice for the evolving Medical Device Industry, aiding our clients as they grow and develop whilst entering new markets and maintaining requirements and changes to current markets. To be the expert to reassure our clients and to guide and inspire them along their growth.

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Services

Our Services.

Our Industry Experts and Dedicated Employees are able to Support you through the Commercialisation of Medical Devices from any stage in the Development Process or Product Lifecycle

Quality Assurance

MDSAP Quality Strategy
GAP Analysis
CAPA Support
QMS Implementation
Auditing Support
Training Support
Interim Management
QMS Maintenance

Regulatory Compliance

Global Market Access,
Notified Body Support,
Post Market Activities,
GAP-Analysis,
Global Registration ,
Local Representation,
Clinical Evaluation Consulting, Auditing

Clinical Affairs

Clinical development plan
Sufficient Clinical Evidence
Clinical Evaluation Plan (CEP)
Literature review
Clinical Evaluation Report (CER)
MEDDEV 2.7/1 rev 4 compliance
Clinical problem solving
Training
Clinical Audit

Risk Management

General risk management enquiries
Risk management planning
Risk management documentation support
Biological evaluation & biocompatibility testing
Risk mitigation support
Risk Management Audit preparation, support & remediation

Training

EU MDR training.
In-Vitro Diagnostics training
ISO 13485:2016 training
MDSAP training
Clinical Evaluations training
Internal Auditing
Risk Management training

Design and Development

Feasibility
Design
Verification
Validation
Design Transfer

Software as a Medical Device (SaMD)

Design
Software Development
Artificial Intelligence (AI)
Validation & Verification
Market Registration
Testing
ISO27001 / 62304 Compliance

MDR and IVDR Transition Support

CE Mark Strategic Planning
Technical File | Design Dossier
EU MDD to MDR Transition
EU MDR Product Approval Requirements
EU MDR GSPR Overview
Product classification and registration of devices
Clinical Evaluation Reports (CER)
Notified Body and EU Competent Authorities Contact
Unique Device Identification (UDI)
Registration of economic operators

Market Mapping & Analysis

Market segmentation
Regional analysis
Market Drivers
Competitive intelligence
Strategic market Research
Market access, pricing & reimbursement
Key trends & forecasts

Let’s talk about your project
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Team

WHAT OUR CLIENTS
SAY ABOUT US

WHY CHOOSE US

We know other companies offer similar services. So why choose us? The answer is simple, the services we provide comes with a proven commitment to quality, security, compliance, delivery, and experience-backed execution. We’re a company of problem-solvers who take complex challenges and turn them into competitive advantages for our clients.

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Winning Awards

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News

Latest News.

The latest news from our Medical Device Team.

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Contact

Get Connected.

We welcome you to contact us for more information
about any of our services.

Let’s Talk About Your Project

Let’s Talk About Your Idea

Let’s Talk About Your Obstacles

CALL: (+44) 208 0497497

UNIT 8B Lancaster Court
Coronation Road
High Wycombe
HP12 3TD

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