Avanti Europe
A Pragmatic Approach toward Medical Device Manufacturing

As the number of medical devices worldwide is growing, the regulations and standards are also rapidly evolving to ensure that the devices are safe, effective, and have the least adverse reactions during use. However, the rapidly evolving regulations are often complicated by legal technicalities. To adapt to changing environment in the medical device industry, medical device manufacturers require a deeper understanding of the regulatory landscape, manufacturing processes, innovative technologies, and more. Even though they have expert administrators and staff, they still face impediments in implementing technologies, developing strategic plans, and setting up intelligent workflows, causing a significant impact on their bottom-line. What they need is a dynamic external consultant who has a thorough understanding of the entire manufacturing processes and the ability to navigate through quality, compliance, and regulatory efforts at each development phase.

This is precisely where Avanti Europe brings to bear their expertise. Switzerland-based consultancy firm, Avanti Europe is at the forefront of assisting medical device manufacturers in crafting and implementing proactive strategies for accelerating their entire product development process and increasing compliance awareness. “Our highly skilled and experienced Experts support with bespoke and flexible solutions during the entire product lifecycle in highly regulated industrial areas such as medical devices, pharmaceuticals, and in-vitro diagnostics,” Fabio Cirillo, managing director of Avanti Europe.

Avanti helps clients monitor—on a global scale—the regulations, standards, and guidelines and provide them with tailored information and flexible project management, quality assurance, and regulatory services. These innovative services are offered through a holistic and end-to-end approach. From ideation through design, development, and project management to quality assurance, regulatory affairs, risk management—and everything else in between, Avanti has it all covered.

The firm’s coherent experts who have hands-on experience support clients during the ideation, development, design transfer as well as industrialisation, testing, and qualification of processes. Besides, Avanti’s highly skilled team helps authorize and verify, the technical documentation that needs to be submitted to regulatory bodies, irrelevant whether it is the U.S. FDA, the EU notified body, or any other authority.

Whether as collaborators in a team or as an external service provider to take on an entire project, Avanti is capable to take on the task. Cirillo accredits the unprecedented success of Avanti to his diverse team of experts who build trust in what they offer and how they approach it—by putting the client first. “We are a cross-functional team that brings vast experiences from different projects and products into the game. We account ourselves to the entire process, and support our clients with the same efforts as we would if it was our project,” he adds.

Our highly skilled and experienced Experts support with bespoke and flexible solutions during the entire product lifecycle in highly regulated industrial areas such as Medical Devices, Pharmaceuticals, and In-vitro Diagnostics

Talking about the advantages of collaborating with Avanti, Cirillo informs, “a client will have complete access and potential suppliers to the interdisciplinary network of the company, which brings only the most brilliant experts into a project team. This allows for a much faster development cycle, a maximally reduced error rate, and—up till now—a 100 percent authority clearance rate.” A case in point that highlights Avanti’s unwavering commitment to helping medical device businesses move forward is its success story with a firm that was looking to enter into a new field of device technology with a novel implant. The client was facing issues in navigating the regulations for the U.S. and the EU. Avanti engaged with the client and conducted a gap assessment to depict a possible development and regulatory strategy towards a successful new product. Acting as a development team member, Avanti assisted the client in bringing their product into the design freeze stage and start the clinical investigation quickly. Furthermore, Avanti also helped them launch the product within 24 hours of receiving authority clearance.

Successes like these are what propel Avanti forward. “Even though external consultants and contractors have an impact on the temporary cost, the long-term knowledge and the best-practice our team brings is critical to driving out-of-the-box thinking to address the technical and medical needs of today’s market,” explains Cirillo. Avanti is currently testing proprietary new digital products to support clients in the regulatory environment. In light of this, the firm is working on automating the monitoring of regulations, standards, and guidelines with smart and AI-powered tools. Alongside, Avanti is also offering additional services as an external PRRC and EC authorised representative for companies willing to enter the EU.