Gap Analysis for MDR/IVDR and other areas:
Documentation and process review solution for Life Sciences
What is a Gap Analysis and how does it help you?
A Gap Analysis is a review and evaluation process where we identify the areas where your processes and documentation do not meet the required standards. This analysis can be applied to various regulations, such as MDR/IVDR, CE marking, technical or clinical documentation, and any other necessary areas. Performing a thorough Gap Analysis allows you to detect and correct identified gaps, optimizing your transition or regulatory compliance.
Benefits of conducting a Gap Analysis
A Gap Analysis ensures your processes align with the required standards, whether for MDR/IVDR compliance or other regulatory areas. Its benefits include:
- Accurate identification of non-compliant processes.
- Faster regulatory compliance.
- Reduction of legal and financial risks.
- Expert advisory for reviewing
any critical area.
Conduct a Gap Analysis for MDR/IVDR or any other area with Ambit BST and ensure your processes are compliant.
Our expert team guides you through every step to optimize your transition or review.
How does Ambit Iberia support you?
Our team of expert consultants works closely with you to identify gaps in your processes. Whether you need to comply with a specific regulation or conduct a general review, we guide you through each step of the analysis, ensuring your procedures are compliant and efficient. Once the review is completed, we provide you with a comprehensive and detailed final report of all findings.
Testimonials from our clients
More than 100 companies in the life sciences sector have already relied on our Gap Analysis for various regulations, such as MDR/IVDR and CE marking. Our customers have praised the efficiency and clarity of our analyses for optimising their processes and complying with regulations.
