Job description Role Title Regulatory Associate – 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 in … Read more
A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – … Read more
Over the years, the amount of regulatory terminology seems to grow at a constant rate, and so it is no surprise that even the more fundamental terms start getting confused. We have seen many cases in which “Intended Use” and “Indications for Use” have been used interchangeably. Sometimes, “Indications for Use” are not even considered! … Read more
Three members of our team will be visiting MEDICA 2017 in Düsseldorf this November. We are available to meet both new and existing clients – please email in advance to arrange an appointment at a convenient time. John Adcock Managing Director john@advena.mt Kenneth Shaw Regulatory Associate kenneth.shaw@advena.mt
A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa. The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of … Read more
Advena Medical have chalked up a remarkable success, and at the first time of asking! Having read and understood the requirements of this new edition of the QMS standard. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our client, the result of which, after a 3 day audit by … Read more
This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now! Manufacturers across the world are not only planning to transition to the … 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. have now identified an insurer who will accept the risks of product liability insurance in accordance with the new regulations, needless to say for Advena as an EU Authorised Representative the premiums will increase significantly, several thousands of pounds higher than previously. The good news is we will be able to continue to … Read more
On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives. These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after … 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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