From the 1st July we welcome Anthony Kirby to our team as Business Manager. (ant.kirby@advena.mt) Anthony joins us with several years’ experience in the medical device industry, the prime responsibilities for this new position will be to act as our contract and administration manager to service all our Authorised Representative, Responsible Person(Cosmetic Directive), ACTIV Quality … Read more
On Friday 28th November, Advena celebrated 5 years at their current location, Pure Offices in Warwick. Visit our twitter page to view the photographs https://twitter.com/AdvenaLtd
We’re pleased to announce that we’ve been granted membership of the SGS Consultants Connect Scheme. This aims to create a community of like- minded consultants who will be able to gain a variety of benefits through their ongoing relationships with SGS United Kingdom Ltd.
The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover: * EN ISO 62304; 2006 medical device software – software life cycle processes * FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff Please … Read more
For those of you visiting MEDICA in Dusseldorf on November 12th to 15th you will find John Adcock and Farhaan Shaikh available to meet face to face on both Thursday and Friday. This is a big opportunity to network so let us know early if you will be there so we can arrange to get … Read more
Quality Management System In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the … Read more
OBL Guidance to Clients This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected. As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained … Read more
SGS Notified Body presented a very interesting Webinar on November 13th (some of you may have been joining in) and this presentation was repeated again during the MEDICA show in Düsseldorf. The story remains unchanged with Notified Bodies making it very clear that from January 2014 the audit processes will be changing for all manufacturers … Read more
Training and managing personnel information plays a vital role in the success of a quality management system. Once trained and skilled, your employees not only ensure the quality of products and services delivered but also work to ensure that the organisation is compliant with industry regulations. This simple ACTIV web-based application was designed so that … Read more
The day before the European Parliament was scheduled to vote on adopting a more FDA-style method of medical device regulation, the central European consumer organization issued a video of medical device horror story testimonials, particularly relating to breast implants. This has not helped industry to fight to avoid radical changes. We (industry) all know that … 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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