Anthony Kirby

Providing EU Authorised Representative Services (EC REP, EU REP, EUAR, EAR), Medical Device Regulatory and QMS Consultancy

Advena Ltd. was founded in 1996 in the UK and provides cost-effective regulatory affairs consulting services to small and medium- sized medical device manufacturers (including start-ups) and distributors seeking to import their medical devices into the European Union. After around 20 years of operating from the UK, in 2016 Advena Ltd established a business in Malta as a consequence of the UK’s decision to leave the EU. This decision allowed Advena to continue offering its primary service as an EU Authorised Representative and as regulatory consultants helping manufacturers to develop their technical documentation. In 2021 it was decided that Advena would de-merge into two clear identities, one operating in the UK and this business operating from Malta, with different independent ownership and management structure. This de-merger was completed in 2022. Our services include: • EU Authorised Representative (EC Rep) • Regulatory consultancy developing technical documentation/files • Assistance with EUDAMED actor registration • Assisting with UDI-DI device registrations on EUDAMED • Medical Device Registrations with the MMA • Italian and other EU national device registrations • Internal Audits • Quality management Systems • Helping clients to find a notified body and the CE Marking process • Certificates of Free Sale For more information and general enquiries please email: info@advena.mt

Commenced as the Business Manager for the EU Authorised Representative business progressing through to become the Managing Director. Due to the result of the UK’s referendum, Advena established a business in Malta and over a period of time transferred all these business activities to the Maltese business. For more information and general enquiries please email: info@advena.mt

Develop UK customer base, offering hospital disposable curtains and roller blinds containing a unique antimicrobial formulation that kills harmful bacteria giving a kill rate of 99.999% (Log 5) in 3 minutes. As a result, significantly reducing the risk of cross contamination / infection. Also developing, supporting All in One Medical's network of export distributors worldwide and identifying new markets. Manage and organise installations and service works within NHS medical facilities in relation to cubicle curtain, tracking and window blind works.

Develop strong sustainable sales of Marlux Medical's infection control portfolio of products (disposable curtaining and hand santiser products) amongst existing export customers worldwide and identify new markets and customers. Provide solid support to the Group Export department in developing sales through distributors in Eastern European territories for Summit Medical orthopaedic accessories (bone cement mixing and delivery systems and autologous blood transfusion products) and Orthomed SAS sports medicine products. Management Representative Duties in respect of the Quality Management System (QMS), formulate, prepare and present quarterly Management Review.

Marlux Medical is part of the the Summit Medical Group Limited Management of all Bids/Tenders and Framework Agreements. Overall responsibility for the Estimating and Contracts Departments, developing ‘New Business’ and awareness of the company’s product portfolio (Disposable patient privacy curtains, cubicle tracking and window blinds) with a variety of commercial contractors or direct with both Private & NHS Hospitals, other medical facilities and Education establishments. Prepare yearly department budgets and monthly forecasts. Attend and contribute at the monthly management board meetings. Prepare reports, charts and performance figures for review at various management meetings. Management Representative duties in respect of the certificated Quality Management System (QMS), formulate, prepare, and present quarterly Management Review. Carefully manage the company’s relationship with the accreditation body. Prepare audit plans, monitor and manage CAPA’s & NCR’s to a successful conclusion.

Overall responsibility of the Design & Estimating Department, The Projects Department and the Customer Service Department; consisting of 15 designers, 18 installers and 10 administration/customer service staff. With the aim of efficiently managing all aspects of submissions and secured contracts with the Social Housing sector, Refurbishments, and New Build contracts.

Set up to manage the restoration of discoloured or "pinked" PVC-u windows on a nationwide basis. GMS Limited set about assisting two system houses in addressing this maintenance issue. Godiva Maintenance Services also installed a full range of PVC-u windows and doors for the commercial sector on a nationwide basis to local authorities, housing associations, house builders and main contractors. Oversee and manage a commercial team of around 30 people. Management of the Estimating Department, the Projects Department and Commercial Installation Department.

Previously owned by Deceuninck one of the worlds largest suppliers of window systems. Godiva Windows manufactured & installed a full range of PVC-u windows and doors for the commercial sector on a nationwide basis to local authorities, housing associations, house builders and main contractors. Oversee and manage a process of change and all contractual obligations. Responsible for a commercial team of over 40 people. Direct management of the Estimating Department and Commercial Installation Department.

Prepare tenders/quotations for local authorities, Housing Associations and Main Contractors, interpreting their requirements from specification documents, bill of quantities, architect’s drawings and a variety of schedules.

Prepare tenders/quotations for local authorities, Housing Associations and Main Contractors, interpreting their requirements from specification documents, bill of quantities, architect’s drawings and a variety of schedules.

Responsible for the control of issuing, receipt and storage of raw materials to both depots and factory areas. Ensuring that stocks are held at minimum optimum levels. Other positions held whilst at Staybrite Include: Production Planning Supervisor Remake Materials Controller Production Planner Clerical Assistant.