Solutions that Work
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We develop and implement innovative strategies for our clients
Custom made solutions to match our client requirements, time limits and budget.
WE EDUCATE We provide a One-Stop Shop for All Your Quality and Regulatory Training and Development needs
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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
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.
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.
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.
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
MDSAP Quality Strategy
Global Market Access,
Notified Body Support,
Post Market Activities,
Global Registration ,
Clinical Evaluation Consulting, Auditing
Clinical development plan
Sufficient Clinical Evidence
Clinical Evaluation Plan (CEP)
Clinical Evaluation Report (CER)
MEDDEV 2.7/1 rev 4 compliance
Clinical problem solving
General risk management enquiries
Risk management planning
Risk management documentation support
Biological evaluation & biocompatibility testing
Risk mitigation support
Risk Management Audit preparation, support & remediation
EU MDR training.
In-Vitro Diagnostics training
ISO 13485:2016 training
Clinical Evaluations training
Risk Management training
Design and Development
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
“Arevna is the goto consultancy for the latest knowledge and trends within the Medical Device industry“
MD, Medical device Company
“The guys at Arevna are brilliant at finding innovative solutions that actually work! It’s truly a one-stop shop for Quality and Regulatory compliance support”
COO, Medical Device Company
“An incredible team full of knowledgeable SME’s who handled our QA RA functions from inception through to commercialization”
CEO, Global Medical Device Company
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.