Regulatory Strategy & Compliance Planning

PracticalRA provides regulatory strategy services for medical devices and in vitro diagnostic medical devices (IVDs) to support efficient market access and sustainable regulatory compliance across global markets.

We work with manufacturers to define clear regulatory pathways, align documentation and evidence requirements, and reduce regulatory risk through structured, forward-looking planning. Our focus is on practical strategy that can be executed, not theoretical advice.

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How We Support

Device Classification

Assessment of device classification and regulatory applicability to support appropriate pathway selection.

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Technical Documentation Review

Structured review of regulatory documentation to identify gaps, risks, and remediation priorities.

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Regulatory Strategy

Regulatory planning to support coordinated market access across multiple jurisdictions.

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Frequently Asked Questions

Questions we commonly receive from device manufacturers looking to navigate regulatory requirements and understand their obligations

Regulatory strategy is most effective when initiated early in development, but it can also be applied to existing products, legacy devices, or portfolios requiring remediation or expansion.

Yes. We support regulatory strategy development for multiple jurisdictions, including the EU, UK, US, Canada and Australia, and can assist with coordinated global planning.

Absolutely. We review existing documentation to identify gaps, inconsistencies, and regulatory risks, and provide practical recommendations for remediation.

No. Our strategy work is practical and implementation-focused, and may include detailed pathway planning, documentation review, and support for execution.

Yes. Clear regulatory planning can reduce delays, minimise rework downstream, and support more predictable submission and review timelines to enable better quality business decisions.

Ensure your compliance with the expertise of Practical RA

Connect with our team of experts to see how we can help you expand into new markets today.

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