Identifying Compliance Gaps

Navigating the complexities of compliance in the medical device industry is a challenging endeavor. At PreCert, our GAP-analyser service for MDR and ISO 13485 is specifically designed to identify compliance gaps in your medical device processes and systems. This crucial service helps ensure that your devices meet all regulatory requirements, paving the way for smoother certifications and market entry.

Why Conduct a GAP Analysis?

Clarity on Compliance: A gap analysis provides a clear, detailed picture of where your current systems and processes stand in relation to the requirements set forth by MDR and ISO 13485. Understanding these gaps is the first step toward achieving full compliance.

Benefits of Our GAP Analysis Service

• Enhanced Compliance Confidence: Rest assured knowing your products and processes meet or exceed all regulatory requirements.
• Reduced Regulatory Hurdles: Minimize issues during regulatory reviews and audits by proactively addressing compliance gaps.
• Improved Product Safety and Quality: Ensure the safety and quality of your medical devices by adhering to industry best practices and standards.

Our GAP Analysis Process

1. Comprehensive Review: We start by conducting a thorough review of your current quality management systems and product compliance to both MDR and ISO 13485 standards. This involves an examination of all relevant documentation, processes, and systems.

2. Detailed Reporting: Following the review, we provide a detailed report outlining the findings, highlighting compliance gaps, and potential risks. This report includes practical recommendations for addressing each identified gap.

3. Action Plan Development: Based on the gap analysis report, we work with your team to develop an actionable compliance roadmap. This plan prioritizes necessary changes and outlines a timeline for implementation.

4. Implementation Support: We offer support in implementing the recommended actions. This includes revising procedures, training staff, and making necessary adjustments to systems and controls.

5. Follow-Up Assessments: Compliance is an ongoing process. We provide follow-up assessments to ensure that all actions have been effectively implemented and to verify continuous compliance with all regulations.