ISO 13485 Certification Renewal: IAG Reinforces Commitment to Excellence in Clinical Trial Imaging
Image Analysis Group, a leading partner in clinical trial imaging, has successfully passed its annual surveillance audit for ISO 13485 certification conducted by the British Standards Institute (BSI). This achievement underscores IAG’s dedication to maintaining the highest quality standards in the development and operation of DYNAMIKA, their proprietary cloud-based platform for clinical trial imaging.
For biotech leaders seeking to optimize their clinical trials, particularly in challenging areas such as rare diseases or complex therapeutic areas, this certification renewal holds significant implications:
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Quality Assurance: ISO 13485 certification ensures that IAG’s quality management system meets international standards specific to medical devices, including software like DYNAMIKA. This provides confidence in the reliability and consistency of IAG’s imaging analysis services.
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Regulatory Compliance: The certification facilitates regulatory approval processes, potentially accelerating time-to-market for new therapies. This is particularly crucial in today’s fast-paced drug development landscape.
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Risk Mitigation: By partnering with an ISO 13485 certified organization, biotech companies can mitigate risks associated with imaging data quality and analysis, a critical factor in clinical trial success.
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Global Market Access: ISO 13485 is internationally recognized, supporting global clinical trials and market access strategies.
Dr. Olga Kubassova, CEO of IAG, emphasized the company’s commitment to continuous improvement and setting new industry standards. This dedication to quality aligns with the needs of biotech leaders who require partners capable of navigating the complexities of modern clinical trials.
By leveraging IAG’s DYNAMIKA platform and their ISO 13485 certified processes, biotech companies can potentially reduce development risks, accelerate trial outcomes, and bring life-saving therapies to patients more quickly. This certification renewal reaffirms IAG’s position as a trusted partner in the biotech industry, capable of delivering high-quality imaging solutions that meet the rigorous demands of clinical research.