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Ant Kirby

Concept of MDR Medical Device Regulation.

EU MEDICAL DEVICE REGULATIONS – PRODUCT LIABILITY

We are still awaiting the final legal opinions for the proposed changes to European law. This will be essential for all manufacturers/distributors/importers selling medical devices into the European Union to have cover for product liability.  The scope of such cover must include all 28 EU states. Should Clients have problems with such cover we are … Read more

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UK/EU REFERENDUM

This is a subject that is on everybody’s lips within all Industries at the moment ……….. The UK population (and ex pats abroad) will be voting on the 23rd June as to whether the UK is to remain in the EU. Whatever the results we assure all our clients that it will be business as … Read more

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Meet Advena at Arab Health 2016

If you are visiting Arab Health 2016, be sure to visit the Advena team on stand Z1C16 in Za’abeel Hall 1. Managing Director, John Adcock, will be available on Monday 25th and Tuesday 26th January, with Anthony Kirby (Business Manager) and Farhaan Shaikh (Regulatory Affairs Executive) available for the duration of the event. We look forward … Read more

Meet Advena at MEDICA 2015

Two members of our team will be attending MEDICA 2015 in Düsseldorf on Monday 16th and Tuesday 17th November. If you would like a meeting please email in advance to arrange a convenient time: Anthony Kirby Business Manager ant.kirby@advena.mt Jacqueline Spittle Quality Manager

New Staff Member at our Warwick Office

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

Advena joins the SGS Consultants Connect Scheme

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.

Concept of MDR Medical Device Regulation.

EN ISO 62304: 2006 Medical Device Software Validation

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

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