Scilife unveils Design and Development solution for medical devices

[Louizalaan, Belgium, 07.15.25] — Scilife announced today the launch of its new Design and Development solution, purpose-built to help medical device companies ensure visibility over design documentation from day one, streamline design control, and accelerate time to market.

Developed in alignment with ISO 13485 and FDA 21 CFR 820 standards, the solution features structured workflows, automated traceability, and centralized version control to keep teams audit-ready while maintaining comprehensive oversight of their design activities.

When developing a new medical device, many companies focus on engineering a functional product, delaying quality and regulatory integration until late in development, sometimes several years into the process. The problem worsens when documentation is scattered across multiple disconnected or paper-based systems, resulting in a fragmented and inefficient approach.

By the time quality assurance and regulatory teams are brought in, they face the daunting task of retroactively collecting—and sometimes entirely recreating—years of critical documentation, including design controls, verification and validation records, CE marking files, FDA submissions, audit documentation, and essential technical data.

Scilife’s Design and Development solution addresses this challenge head-on by guiding product and quality teams through compliant documentation practices from day one—helping avoid the compliance wall and costly reworks.

Understanding the weight of this challenge, Scilife’s teams rolled up their sleeves. Product, Engineering, and QA came together to build a solution that not only solves the problem—but does so in the way we expect quality to work: collaboratively, proactively, and by design.

“Our Design and Development solution is the result of true cross-functional collaboration. All teams worked together across Product, Engineering, and QA, applying the same philosophy we bring to our customers: quality should be embedded into every aspect of development, not treated as a separate function.”

Roozbeh Farahbod, CTO, Scilife.

By deeply engaging with customers, we identified the everyday gaps in design control processes—and built a solution that closes them. The result underscores Scilife’s ongoing commitment to solving real customer problems. Rather than layering on features, we focused on what truly matters: reducing friction, improving traceability, and ensuring compliance from the start.

The result embodies Scilife's longstanding beliefs—voiced by Roozbeh Farahbod—that great technology is defined by its ability to simplify the complex.

With the automated traceability matrix, 21 CFR Part 11 compliant electronic signatures and the version comparison tool, this solution equips teams with an extensive toolset to manage their design control lifecycle in one place. This enables medical device companies to remove roadblocks on the way to market while maintaining compliance with ISO and FDA requirements.

“By adding the new Design and Development solution to the Scilife suite, we’re solving an all too familiar problem in the medical device sector: teams racing toward market, only to hit a compliance wall. By embedding design control documentation into an intuitive, traceable workflow from the very beginning, we help companies reduce the cost of quality and avoid delays.”

Sébastien Bohn, VP of Product Management, Scilife.

Through this solution, we’re tackling one of the most common and costly seatbacks in medical device innovation: reaching the finish line, only to be blocked by regulatory gaps.

And this is just the beginning. At Scilife, we’re committed to constantly raise the bar. Upcoming releases will introduce powerful enhancements, such as a streamlined regulatory submission workflow and built-in automated risk management, which will make it even easier for MedTech teams to move faster, stay compliant, and bring products to market with confidence.

About Scilife

Scilife is on a mission to turn quality into a force for growth in life sciences. Since 2017, we’ve helped companies move beyond reactive compliance and brought clarity, control, and speed to their quality management processes.

Trusted by global quality-focused organizations, including Novartis, Biocartis, Yusen Logistics, Polpharma, and Pendulum, Scilife is committed to improving efficiency, simplifying regulatory compliance, and making quality an engaging culture for everyone on board. The impact? Improving patients’ lives.

Curious to know how the new Design and Development solution can help your organization? Get in touch with us!