28 GHP / Q3 2021 GHP / Q3 2021 29 , Jun21113 Bespoke, Flexible Solutions Bespoke, Flexible Solutions Avanti Europe is your first address in the end-to-end support of medical device and combination products development and product support. Starting with an idea or the intend of conquering a newunmet medical need, Avanti Europe supports in innovation, development, market introduction, market surveillance as well as QA and regulatory strategy. Global Health & Pharmamagazine has recognised Avanti Europe as outstanding in its field and has awarded it the title of Best Specialist Medical Devices and In-Vitro Diagnostics Consultancy 2021 – Switzerland. Join us as we learnmore about the company. Throughout development, Avanti Europe’s experts support with hands-on experience and specialist knowledge in the user-centric and risk-based approach to novel products and services. It serves all business sizes, from start-ups, to small- to mid-sized companies, to enterprises, and it approaches them through the ecosystem of ImpactHubs, Incubators, networking events, conferences, training, as well as NCOs. From lab to manufacturing, Avanti Europe supports during design transfer and manufacturing equipment specification, engineering, testing and qualification. Along with the technical support, its expert author technical documentation ready to be submitted to the authorities, whether the US-FDA, the EU Notified Body, or another authority. Support is given during post-market surveillance in the same quality as for any other step in the product lifecycle. Avanti Europe can support over the entire range of product lifecycle with a coherent team of experts who assist with clients’ bespoke needs. The company’s core value is based on “fair business as tailored support of premium quality”, which it has absorbed in everything it does, from agreements, to tailoring its service, to lasting co-operations and networking in the industry. Within the last five years of Avanti Europe’s being, the team has excelled from a start-up to an award-winning consultancy and contracting firm, thanks to its core value. Avanti Europe’s staff are always at the forefront, representing the values of the company and providing a high level of expertise and initiative to those who require support. Contributing to the team with their expertise, employees remain calm during hectic times, bring in their opinion and listen to other opinions before recommending or voting in favour of a strategy or solution. In collaborating with Avanti Europe, clients have access to the interdisciplinary network of Avanti Europe, which brings only the most brilliant experts and suppliers into a project team and allows for fast and reliable answers to complex questions. Paired with the decade-long experience in product development, industrialisation and market support, Avanti Europe brings major benefits to the table as its experts navigate the regulatory, technical and quality requirements on a global scale. The benefits are a much faster development cycle, a maximally reduced error rate, and, up until now, a 100% authority clearance rate. It might also be beneficial to point out that external consultants and contractors of Avanti Europe bring the advantage of fast onboarding and vast knowledge of the industry to support clients. Even though external consultants and contractors might have an impact on the temporary cost, the long-term gain in knowledge and best practice is superior to temporary staff or other forms of external help. The major plus lies here in the multidisciplinary team involved in many different product development projects which bring out-of-the-box thinking and new solutions to technical and medical needs. While the company has seen significant success, it has also seen a continuous challenge in the form of constant evolvement of the state-of-the-art, shown in the many different and changing standards, guidelines and regulations. This cumulated in the introduction of the IVDR 2017/746 and MDR 2017/745. The transition of these regulation changes finds an additional challenge for Swiss and EU manufacturers who are exporting from or importing into Switzerland. With this, Avanti Europe is currently facing a higher demand in required support service. The company ambitiously looks forward, continuing to serve its clients in view of its core value, while constantly striving for excellency in all that it does. Doubtlessly, 2021 will be another challenging year overall, with the changes in the regulation for medical devices, the expected change for the IVD market in the EU, and specifically the challenges arising from the halted MRA negotiations between Switzerland and the EU. Contact: Fabio Cirillo Email:
[email protected] Website: www.avanti-europe.ch