Advena Ltd
Advena Ltd is a specialized consultancy firm with over 25 years of experience in providing EU Authorised Representative (EU REP) services, regulatory affairs, and quality management support for medical device manufacturers. Established in 1996 and now based in Malta, Advena Ltd helps clients navigate the complexities of EU Medical Device and In Vitro Medical Device Regulations, facilitating access to the EU market. Their services include acting as an EU Authorised Representative, offering consultancy on technical documentation and quality management systems, and providing importer services. Advena Ltd is certified to ISO13485:2016 by IMQ and is a founding member of the European Association of Authorised Representatives (EAAR). They focus on supporting start-ups and small to medium-sized manufacturers, ensuring a strong client experience and regulatory compliance. Advena Ltd also assists with EUDAMED Actor Registration, helping manufacturers obtain their Single Registration Number (SRN) to ensure smooth operations within the EU regulatory framework. Their team of experienced professionals is dedicated to carrying the burden of responsibility with cost-effective regulatory solutions.
Key Highlights
-
Over 25 years of experience as an Authorised Representative (EU REP).
Source
“With over 25 years of experience as an Authorised Representative (EU REP) you will benefit from our expert knowledge.”
-
Provides support for navigating EU Medical Device and In vitro Medical Device Regulations.
Source
“we provide support and assistance that helps our clients navigate the complexities of the EU Medical Device and In vitro Medical Device Regulations”
-
Assists with EUDAMED Actor registration to obtain an Actor ID/SRN.
Source
“The module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number (Actor ID/SRN).”
-
Offers services related to UDI/Devices registration within EUDAMED.
Source
“UDI/Devices registration.”
Certifications & Trust Signals
-
Established consultancy with extensive experience in medical device regulations.
Source
“With over 25 years of experience as an Authorised Representative (EU REP) you will benefit from our expert knowledge.”
Buyer Snapshot
Best for
- Companies seeking EU Authorised Representative services.
- Manufacturers needing support with EU MDR/IVDR compliance.
- Businesses looking to register on EUDAMED.
How engagement typically works
- Consultative approach to regulatory challenges.
- Focus on client-specific needs for market entry.
- Support for navigating complex EU regulations.
Typical deliverables
- EU Authorised Representative registration.
- EUDAMED Actor registration and SRN.
- Technical documentation and QMS preparation.
- Regulatory Importer compliance support.
Good to know
- Best when clients require specialized knowledge of EU medical device regulations.
HQ:
Swatar, MT
Languages:
English
Timezones:
UTC+1
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
Actor/SRN
Submission Approach:
Portal
Managed Service Available:
Yes
Additional eudamed_onboarding_support Details
Modules Supported
Actor registration, UDI/Devices registration, Notified Bodies and Certificates, Clinical Investigations and performance studies, Vigilance and post-market surveillance, Market Surveillance
Submission Approach
Portal operations for Actor registration.
