Advena are exhibiting at FIME 2019, this trade fair is considered one of the most important across the Americas and is taking place at the Miami Beach Convention Center in Florida. Advena will be located at booth B45 in the gold zone, at this important show in Miami from 26th to 28th June 2019. We … Read more
A publication released by the MHRA on the 4th January, updated on the 26th February explains how the UK will regulate all medical devices under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). Whilst all those devices currently CE … Read more
Advena Limited, Malta have chalked up a remarkable success! Following the successful re-certification audit at our UK office at the end of February 2019, the next task was to audit our office in Malta (an EU27 member state) for inclusion on our ISO 13485:2016 certification. Advena’s experts set about this tricky task providing carefully planned advice … Read more
Advena will be located in Za’abeel Hall 4, Stand Z4 J43 at this important show in Dubai from 28th to 31st January 2019. We will be available to meet existing and prospective clients during this trade show. We advise those who would like to meet one of our team to email for an appointment (info@advena.mt) … Read more
Even now after the draft text of the withdrawal agreement has been agreed by Government, there remains considerable uncertainty regarding the commercial impact of Brexit and how this will affect UK based medical device manufacturers who CE mark devices. As we have done over the last 2 years, we at Advena track UK political news … Read more
Software within the healthcare industry is exploding with innovation so much so that regulation is only now starting to catch up!, making software key to a medical device revolution. Software is now incorporated within many medical devices including smartphones. This means that such software and applications must abide by the relevant EU legislation and must … Read more
There is considerable uncertainty regarding the commercial impact of Brexit and how this will affect medical device manufacturers who CE mark devices and use a UK based EU Authorised Representative (EC REP) and label their devices with a UK address. Here at Advena we track the UK political news closely and feel now that unless … Read more
Notified Bodies seem to be placing greater scrutiny on medical device manufacturers who have appointed an EU Authorised Representative (EC REP) with particular reference to unannounced audits. As many of you may already know, Notified Bodies now consider the EC REP a critical subcontractor and are therefore subject to an unannounced audit by the manufacturer’s … Read more
As many of you will already know, the requirements regarding Post Market Clinical follow up and Post Market Surveillance have increased dramatically in recent years. This is not only a result of the changes made within MEDDEV 2.7/1 Rev 4 June 2016 but also Clause 8.2.1 and 8.2.3 of ISO 13485: 2016, and in addition … Read more
ISO13485:2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard. Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version and become certified. In addition if it’s your intension is to access USA, Brazilian, Japanese, … Read more
Advena Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 76865
Advena Services Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 103067
Advena Malta (Holdings) Ltd
Registered Address:
Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474
Advena SRL
Registered Address:
Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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