Health Care Case Studies

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Background:
A leading healthcare medical device provider, MedTech Innovations, specializes in advanced diagnostic equipment. They operate in a highly regulated industry, requiring strict adherence to FDA medical device standards and ISO 13485, which specifies requirements for a comprehensive
quality management system for the design and manufacture of medical devices.

Challenges:
Rapidly Evolving FDA Regulations:
The FDA frequently updates its regulations to ensure medical devices meet the highest safety and effectiveness standards. For MedTech Innovations, keeping pace with these changes means constantly updating device specifications, clinical trial protocols and manufacturing processes. An
example includes the recent FDA guidance on digital health technologies, requiring MedTech Innovations to revise their software development lifecycle documentation to ensure compliance.

Extensive Documentation Management:
MedTech Innovations must maintain a vast array of documentation, including design specifications, manufacturing records, and quality control reports. Each product line could have thousands of pages of documentation. Managing this volume, especially ensuring that changes in one document are
reflected across all relevant documents, presents a significant challenge. For instance, a minor change in device material must be updated in design documents, manufacturing instructions and safety assessments.

Ensuring Consistent Compliance:
Adhering to ISO 13485 requires that all of MedTech Innovations' device specifications, policies and procedures are consistently compliant with both FDA regulations and international standards. This involves rigorous internal audits and regular updates to training programs. An example is ensuring that their latest cardiovascular device line meets the updated ISO standards for biocompatibility testing, necessitating a comprehensive review of all related documentation and processes.

Penalties for Non-Compliance:
The consequences of non-compliance can be severe, including fines, product recalls, or even criminal charges. For example, a competitor recently faced a multi-million dollar fine and a mandatory recall of several products due to failure to comply with FDA reporting requirements for adverse events, highlighting the financial and reputational risks.

Delays in Product Launches:
Delays are often caused by the time-consuming process of compiling, reviewing, and submitting the necessary documentation for regulatory approval. A specific delay MedTech Innovations faced was a six-month postponement of a new imaging device launch due to incomplete risk analysis documentation, significantly impacting their market entry strategy and financial projections.

Solution with Koru Compliance Platform:
MedTech Innovations utilizes the Koru Platform to adeptly manage and ensure compliance with FDA and ISO 13485 standards, leveraging its specific capabilities as follows:

Direct Analysis for Regulatory Compliance:
MedTech uses the Koru Platform to analyze compliance documentation against current FDA standards. This direct application of Koru's AI and machine learning technology enables the company to efficiently identify areas requiring updates due to regulatory changes, streamlining the
maintenance of compliance documents.

Streamlined Documentation Management:
By employing Koru, MedTech Innovations can effectively manage the extensive documentation required for compliance. Koru's analysis and cross-referencing capabilities ensure that all device specifications, policies, and procedures are consistent and up-to-date, simplifying the complex task of document management in a heavily regulated environment.

Proactive Compliance Across Standards:
The company leverages Koru to maintain alignment with both FDA regulations and ISO 13485 standards. Through precise analysis, Koru identifies potential discrepancies in compliance, enabling MedTech Innovations to proactively address these areas and maintain a robust
compliance posture.

Efficiency in Compliance and Risk Mitigation:
MedTech Innovations capitalizes on Koru's efficiency to mitigate risks associated with non compliance and to expedite the compliance review process. This proactive identification and resolution of compliance issues help avoid potential penalties and reduce delays in product launches, facilitating a smoother path to market for new medical devices.

Outcome:
The adoption of the Koru Compliance Platform transformed MedTech Innovations' approach to regulatory compliance. The platform's efficiency in managing and analyzing documentation allowed the company to navigate the complex regulatory environment confidently, maintain its commitment to
quality and safety, and achieve a faster time-to-market for its innovative medical devices.