Turning Regulation into Opportunity: Meet Yaniv Menachem

Innovation in the medical devices industry isn’t just possible—it’s essential. But turning a strong idea into a viable product requires a clear understanding of the global regulatory standards that shape development, manufacturing, and market access.

As Regulatory Affairs Manager at Elcam Medical, Yaniv Menachem helps teams translate regulatory requirements into practical guidance they can use throughout development.

Regulation as an Enabler, Not a Roadblock

Regulatory compliance is often perceived as a roadblock, slowing down creativity and innovation. But done right, Regulatory Affairs can become an essential enabler of everything that Elcam does.

By guiding teams from the earliest stages, the RA department helps them make better decisions and avoid unnecessary delays. 

“When Regulatory Affairs is involved from the beginning, it gives the development team and the company a clear framework,” Yaniv says. “They can move forward quickly, knowing they’re protected and heading in the right direction.”

That early guidance shapes both the product and the processes used to develop and manufacture it, clarifying testing, documentation, and quality requirements before preventable changes become costly. 

Regulatory Affairs becomes a way to strengthen the product and the process, rather than simply another hurdle to clear.

Navigating a Constantly Changing Global Landscape

The task of keeping up with regulation becomes more complex when a product is aimed at multiple markets, each with its own requirements for medical devices. 

Keeping legal market approvals valid and compliant in several jurisdictions at once is rarely simple. Each market has its own specific requirements, both for the product itself and for the quality system behind it, and these don’t always line up. What makes it manageable is depth: once the team has a solid handle on the underlying requirements, moving between markets and adapting to local differences gets a lot faster, especially once those markets are familiar and the work has been planned for in advance. After approval, that groundwork continues to be valuable when it comes to keeping  product registrations current across every jurisdiction throughout each product’s lifespan. And multi-jurisdiction projects operate more smoothly when the authority interactions involved are mapped out and coordinated ahead of time. It saves real time and heads off problems, both during development and at market entry. 

For the Regulatory Affairs team, differences between jurisdictions affect decisions made long before a submission begins, from product classification and testing to documentation and quality-system planning.

“Working across different markets, regulatory bodies, and partner organizations is challenging, but it also helps us keep learning,” he says. “These processes can take years, so the broad experience we’ve gained over the years from all our activities at Elcam Medical helps us prepare well in advance, adapt, and respond to changes relatively quickly.”

Forward planning, together with the knowledge and experience accumulated within the team, proved valuable, for example, as Elcam adapted to changing European requirements. Rather than waiting until the end of the transition period, the company began planning early and completed the necessary product and quality-system approvals in 2023. 

The lessons gained through that process also helped Elcam’s Regulatory Affairs team support another company in the group to achieve CE certification for a relatively advanced and complex product within a relatively short timeframe.  

Collaboration as a Key to Success

At Elcam, Regulatory Affairs works closely with R&D, Quality, Manufacturing Engineering, subsidiaries, and subject-matter experts throughout the development process.

“Most of the required documentation, especially for submissions, but also for responses to regulatory authorities, is developed in collaboration with the relevant experts across Elcam,” Yaniv says. “That cooperation has been one of the keys to our success.”

That collaboration helps turn regulatory requirements into practical decisions. Engineers understand the product and manufacturing processes in depth. Quality teams bring their own expertise in systems and controls. And Regulatory Affairs connects those technical perspectives to the requirements of each market. 

The result is a development process grounded in both technical realities and regulatory expectations. Not only is the entire process conducted in full compliance with the applicable regulatory requirements, but it is also presented to the reviewing authorities in a clear, transparent, and professional manner. This improves the overall efficiency of the review process and provides confidence that both the products and the company responsible for them comply with the applicable requirements and have a thorough understanding of the regulatory expectations. 

Thinking About Regulation from Day One

At the start of each project, Yaniv and his Regulatory Affairs team map out the regulatory path ahead. 

“Our involvement begins with a regulatory assessment at the very start of the project,” he explains. “We identify the applicable product and quality-system requirements, translate the standards and regulations into practical checklists, and build all of these into the product requirements from the beginning.”

From there, the team stays involved through development, submissions, product changes, and post-market activity. That continuity helps Elcam respond as requirements evolve, both before a product reaches the market and after launch.

Where Compliance Adds Value

Led by Yaniv, the Regulatory Affairs team helps other departments within Elcam find a practical route through what can seem like a complex maze of opaque requirements.

For Elcam’s partners, that contribution makes the development process more manageable and supports better long-term planning. It can also open the way to additional markets.

Yaniv sums it up with an analogy he often uses when training colleagues: “These are the rules of the game. Once teams understand them, it lightens the regulatory burden. They know where they’re going, and they have a clear framework for success.”