There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to … Read more
The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices. A single-use device, as is implied by its name, is a device which is intended to be used on a single patient … Read more
Advena will be located in Za’abeel Hall 4, Stand Z4 E40 at this important show in Dubai from 30th January to 2nd February 2017. 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 … Read more
This article has been updated! Please visit the following link: https://www.advenaltd.eu/news/5935/reusable-surgical-instruments-in-eu-regulation-7452017/ The upcoming EU Medical Device Regulation brings with it several new device classification and one specifically involves Class I Reusable Surgical Instruments. Which are defined as: “an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar … Read more
The safety of battery operated devices is attracting increasingly stringent scrutiny and it has been determined that, as from 1 May 2012, all lithium-ion batteries must be tested and certified to the standard IEC 62133. The exceptions are for information technology equipment (standard IEC 60950-1 applies) and audio/video devices where IEC 60065 applies. This includes … Read more
Across three key areas, the results of Advena’s Client Satisfaction Survey for 2016 are testament to our policy of continuous improvement right across our service provision: 1. Value We asked clients if they thought Advena provided an extremely competitively priced service – none of the respondents disagreed. 2. Efficiency 98% of respondents agreed that Advena … Read more
Two members of our team will be attending MEDICA 2016 in Düsseldorf on Monday 14th and Tuesday 15th November. We are available to meet both new and existing clients – please email in advance to arrange an appointment at a convenient time. Anthony Kirby Business Manager ant.kirby@advena.mt Zennia Paniwynk Quality/Regulatory Administrator
The Business Desk West Midlands “Warwick firm adopts Maltese registration to improve EU trading” http://www.thebusinessdesk.com/westmidlands/news/739349-warwick-firm-adopts-maltese-registration-to-improve-eu-trading.html Coventry Telegraph “Advena Limited is based in Warwick and will retain all of its operations in the UK, but has set-up an office in Malta where the business is now registered as a subsidiary.” http://www.coventrytelegraph.net/news/business/brexit-forces-warwickshire-business-move-11832211 Advena are prepared, by active … Read more
Thanks to our new trusted partners in Argentina we are being represented at ExpoMedical medical device trade show in Argentina. This show is at the Centro Costa Salguero; Av. Costanera R. Obligado y J. Salguero Buenos Aires Argentina and runs from the 28th to 30th September. Advena Ltd will be represented at Booth # 5 … Read more
This is a follow-up on the news we provided in our Newsletter last month concerning the EU regulatory changes that could occur following the decision for the UK to leave the European Union, a decision referred to as Brexit by the media. This outcome of this may be relevant as Advena Ltd are a UK … 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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