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Quality and Test Engineering

Regulatory compliance is a complex challenge for medical device teams, and with FDA staffing constraints potentially slowing reviews and approvals, adopting a proactive approach is more critical than ever to mitigate the risk of delays and added regulatory hurdles. In this guest post,&nbsp;<a href="https://www.linkedin.com/in/kent-kallsen-0b8a513/" target="_blank">Kent Kallsen</a>, Delve's former VP of Program Development, shares why embracing risk management, human factors, and robust documentation is essential to navigating this evolving landscape.

We've been developing medical devices to meet rigorous standards for 55 years.

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<h2>No Room for Shortcuts</h2>
With <a href="https://www.reuters.com/world/us/trump-is-firing-federal-workers-who-are-not-funded-by-taxpayers-2025-02-21" target="_blank">recent reports indicating staffing reductions at the FDA</a>, it's not hard to imagine that future submissions could start to take longer to receive feedback, and pre-submission meetings may become more difficult to schedule. That uncertainty makes one thing very clear: you cannot afford to take shortcuts in medical device development.
The reality is that a rushed or incomplete submission will only lead to delays, additional questions, and more back-and-forth with regulators—costing valuable time and resources. Instead, the focus must be on proactive risk mitigation and robust documentation. To stay ahead of these challenges, it’s essential to build a proactive strategy around core areas like risk management, human factors, and documentation.
<h2>What It Takes to Stay Ahead</h2>

Quality management systems get a bad rap for slowing down progress and squelching innovation. We developed our own QMS approach to meld rigorous standards and the flexibility to innovate.

Don't Miss: QMS that works for us—and our clients

<ul><li>A Risk-Based Development Plan.&nbsp; Ensure your design process is built around identifying, assessing, and mitigating risks upfront. For example, implement regular risk assessment workshops during the early design phases to proactively identify and address potential issues before they become obstacles. </li><li>Human Factors and&nbsp;Usability Engineering. Minimizing usability risks through well-executed human factors studies is not just a best practice—it’s an expectation. Conducting comprehensive human factors studies not only meets regulatory expectations but also enhances user satisfaction and reduces the likelihood of user errors, improving overall device performance and safety. </li><li>A Comprehensive Design History File (DHF).&nbsp; A well-structured DHF should clearly demonstrate that user needs have been properly cascaded into design requirements, and that your device meets regulatory expectations through thorough verification and validation. Maintaining an organized and accessible DHF facilitates smoother audits and accelerates the approval process, ensuring a more efficient path to market.</li></ul>
But documentation isn’t just about meeting regulatory requirements—it should also enable efficiency and innovation.&nbsp;

With today’s increased uncertainty around future FDA resourcing, a purely reactionary submission strategy is risky at best. A proactive strategy will undoubtedly reduce both schedule and product risks, ensuring a smoother path to market.
At Delve, we’ve developed a <a href="https://www.delve.com/insights/qms" target="_blank">tiered Quality Management System</a> (QMS) that aligns with ISO 13485 standards and FDA regulations. This approach ensures compliance while maintaining the flexibility to tailor processes to individual client needs, fostering both innovation and efficiency.
By embedding compliance and best practices early in development—rather than treating them as last-minute hurdles—our QMS plays a crucial role in reducing costly delays and regulatory setbacks. It supports teams in proactively managing risks, allowing them to stay ahead of challenges without compromising speed or innovation. In an environment where agility and foresight are paramount, partnering with a development team that prioritizes proactive risk management and robust documentation can make all the difference. By partnering with experienced teams that prioritize compliance, risk mitigation, and innovation, medtech companies can stay ahead of the curve and accelerate their path to market.

Learn more about&nbsp;<a href="https://www.delve.com/medical-devices" target="_blank">Delve Product Development Services for Medical Devices.</a>

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In a climate of regulatory uncertainty, there’s no room for shortcuts. Rigorous risk management, human factors, and a well-structured DHF aren’t just best practices; they're critical.

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In a climate of regulatory uncertainty, there’s no room for shortcuts. Rigorous risk management, human factors, and a well-structured DHF aren’t just best practices; they're critical.

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Now More Than Ever: No Shortcuts in Medical Device Development

Now More Than Ever: No Shortcuts in Medical Device Development

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