Regulatory Pathway

You wouldn’t build a house without a blueprint, so why attempt to navigate the complex regulatory landscape without a clear and defined strategy?

At RQMIS, we develop comprehensive medical device regulatory strategy documents tailored to specific geographic regions. These documents serve as a roadmap to achieving regulatory clearance and market entry while minimizing risk and avoiding unnecessary delays.

A well-defined regulatory strategy document isn’t just a roadmap—it’s your key to achieving market success efficiently and compliantly.

What Does Our Regulatory Strategy Document Include?

Clearance Pathway Analysis:

• Detailed outline of the regulatory clearance pathway specific to your target market.
• Identification of submission types (e.g., 510(k), PMA, CE Mark, or other regional requirements).

Product Classification Rationale:

• Precise classification of your medical device based on regional regulations.
• Justification for the chosen classification pathway.

Regulatory Submission Roadmap:

• Step-by-step guide to the submission and approval process.
• Identification of key milestones and anticipated timelines.

Standards and Compliance Requirements:

• Overview of relevant quality standards (e.g., ISO 13485, ISO 14971) and regulatory frameworks.
• Guidance on design control documentation requirements.

Preclinical and Clinical Study Requirements:

• Identification of necessary preclinical testing and clinical study protocols (if applicable).
• Recommendations for efficient study design and implementation.

Labeling and Documentation Requirements:

• Clear guidelines on labeling requirements, user manuals, and other regulatory documentation.

Quality System Considerations:

• Detailed review of Quality Management System (QMS) expectations for the target market.
• Recommendations for establishing or improving QMS process