All of the following points should be considered in relation to the new legislation: a). There is a high emphasis on the need to audit the premises of the (legal) manufacturer and also critical subcontractors and suppliers. This will lead to the need to visit all manufacturers annually including own brand labellers and to increased … Read more
Here at, Advena Medical Ltd, we firmly believe that a smooth transition to a digital – paperless document workflow can set up an organisation for success, which is why we’ve developed an in-depth QMS System called ACTIV to assist our partners as they make the switch. We have noticed that more and more organisations are switching … Read more
It is obvious that test laboratories are getting totally bogged down with the testing to EN ISO 60601-1 3rd edition. We recently got a message from Intertek that they could not take on any more EN ISO 60601-1 3rd edition testing as the risk management phase was taking too long and they did not have … Read more
The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014. The changes would reflect: v The new EU regulation structure and system … Read more
QMS can help your business to: 1) Achieve greater consistency in the activities involved in providing products or services. 2) Reduce expensive mistakes. 3) Increase efficiency by improving use of time and resources. 4) Improve customer satisfaction. 5) Market your business more effectively. 6) Exploit new market sectors and territories. 7) Manage growth more effectively … Read more
Manfred Koehler of the European Commission (in charge of European regulation for medical devices, SANCO Eurocrat and lawyer) joined the European Association of Authorised Representative (EAAR) on 26th September 2013. He went straight to the point that the European Commission consider the regulatory responsibility of Authorised Representatives (AR) for self-certified medical devices to be on … Read more
John Adcock – Managing Director Advena Ltd will be speaking at the ‘Medilink Design & Innovation Masterclass’ at Medilink West Midlands, Medical Technologies Innovation Centre, 4 Greenfield Crescent, Edgbaston, Birmingham, B15 3BE on Wednesday 25th September – 9:30am – 4:00pm John will be sharing his experience and providing good practical advice on Regulatory considerations at the … 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
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Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474
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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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