The Post-Market Clinical Follow-up (PMCF) is a post market activity which should form part of a manufacturer’s PMS plan. It consists of proactively collecting and evaluating clinical data related to the use of a CE marked device already on the market. The aim of the PMCF is to confirm the safety and performance of the … Read more
As a medical device regulatory and quality management (QMS) consultancy we place considerable value in holding our own ISO13485:2016 certified QMS. We are therefore pleased to announce receipt of our new ISO13485:2016 certificate covering the following scope ‘European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers’. Having … Read more
This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert. Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as … Read more
This month we welcome Dr Andrew Whitton to our team at Advena Medical Ltd., as a Senior Regulatory Consultant. Andrew brings a broad wealth of knowledge and experience in medical device regulatory having previously worked in a number of senior regulatory roles and with many devices including IVDs, combination products, cardiovascular and wound-care devices, across … Read more
Following an intense 3 day ISO13485 transition audit we are pleased to announce Advena Limited & Advena Medical Limited have been recommended for ISO13485:2016 certification. This remarkable achievement is all the more impressive as it included a transfer from BSI to LRQA. Underpinning our ability to offer QMS consultancy to medical device manufacturers worldwide. If … Read more
Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role. Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question; “Can you trust your … Read more
There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK. Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable. This is emphasised by the UK Notified … Read more
It would seem Intertek have sent out co-ordinated information regarding their future certification activities, we have now heard from multiple sources and can confirm the following important information: Intertek has chosen to centralise its Notified Body activities to Intertek Semko AB (NB No 0413) in Kista, Sweden (SEMKO). This will lead to the closure of … Read more
Advena will be located in Hall 7, Stand H7C50 at this important show in Dubai from 29th January to 1st February 2018. We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would like to … Read more
Job description Role Title Senior Regulatory Consultant – Medical Devices Location Office Based in Warwick, United Kingdom Rewards Competitive salary. About Us Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office … 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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