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Quality Assurance and Compliance

Bioexcel Medical Device Research Organisation offer

Quality Assurance and Compliance

Bioexcel ensures that medical devices not only meet the highest standards of quality but also adhere to the necessary regulations. This, in turn, enables clients to navigate the complex regulatory landscape, secure approvals, and maintain the safety and effectiveness of their products throughout the development and marketing process.

The Quality Assurance and Compliance services provided by Bioexcel, including Quality Management Systems and Regulatory Compliance, are critical for ensuring that medical devices meet high-quality standards and adhere to the necessary regulations. Here’s a detailed explanation of each service:

Quality Management Systems:

  • Adherence to ISO Standards: Bioexcel maintains strict adherence to International Organization for Standardization (ISO) standards, such as ISO 13485, which is specifically designed for quality management systems in the medical device industry. This ensures that your medical devices are manufactured, tested, and documented in a consistent and standardized manner.
  • Industry Best Practices: Bioexcel follows industry best practices in quality management, integrating principles such as risk management, continuous improvement, and process validation. This results in robust quality control, efficient processes, and a focus on enhancing product quality.

Regulatory Compliance:

  • Ensuring Compliance with FDA Regulations: Bioexcel helps clients maintain strict compliance with regulations set forth by the FDA, which is a critical aspect of marketing and selling medical devices in the United States. This involves ensuring that the devices are manufactured, tested, and documented in accordance with FDA requirements.
  • Compliance with International Regulations: Bioexcel services extend to ensuring that medical devices meet international regulatory standards as well. This includes compliance with regulations set by regulatory bodies in various countries or regions, depending on where clients intend to market their devices.
Help & FAQ

Frequently Asked Questions

Quality Assurance and Compliance services at Bioexcel are essential to ensure that your medical device development adheres to industry best practices and regulatory standards. They guarantee that your device is of the highest quality and meets the requirements for safety and effectiveness.

Bioexcel implements comprehensive Quality Management Systems (QMS) that cover all aspects of your project. This includes rigorous design controls, document control, risk management, and performance monitoring to maintain consistent product quality.

Bioexcel's compliance experts closely monitor evolving regulations and ensure that your project aligns with the latest FDA and international regulatory requirements. We conduct regular assessments, audits, and reviews to maintain compliance throughout the development process.

Bioexcel is proactive in monitoring regulatory changes and updates. When new regulations are introduced, our team quickly adapts project strategies to ensure ongoing compliance, reducing the risk of regulatory non-compliance.

Quality Assurance and Compliance are critical in PMS and PMCF. Bioexcel ensures that data collected during post-market phases aligns with regulatory requirements, maintaining product quality and safety while monitoring device performance