Comprehensive Solutions for Global Quality Compliance
At Bioexcel, we specialize in delivering tailored quality management and compliance services for medical device manufacturers. Our expertise ensures that your processes, systems, and products adhere to global quality standards, enabling efficient market access and sustained regulatory compliance.
Why Quality Management is Critical for Medical Devices
The medical device industry operates in a highly regulated environment where quality management is essential to ensure safety, performance, and reliability. Compliance with standards like ISO 13485, FDA Quality System Regulations (QSR), and EU MDR requirements is mandatory to demonstrate that your device meets regulatory expectations and delivers on its intended use.
Key Benefits:
Robust Systems for Streamlined Compliance
We help you design, implement, and maintain a Quality Management System (QMS) aligned with ISO 13485 and other global standards.
Key Features:
Identify and Resolve Quality Gaps
Our experts conduct comprehensive audits to identify non-compliances and recommend corrective actions.
Key Features:
Ensuring Consistency and Reliability
We support you in validating critical processes, equipment, and methods to ensure product consistency and compliance.
Key Features:
Strengthen Your Supply Chain
We ensure that your suppliers meet quality and compliance standards, reducing risks in your supply chain.
Key Features:
Proactively Address Risks Across the Lifecycle
We assist in implementing risk management processes that comply with ISO 14971 to mitigate potential device risks.
Key Features:
Sustaining Compliance Beyond Approval
We provide post-market quality services to ensure your devices remain compliant with evolving regulations and real-world requirements.
Key Features:
Challenge:
A medical device startup needed to implement a QMS compliant with ISO 13485 to meet regulatory requirements for CE marking.
Solution by Bioexcel:
Outcome:
Challenge:
A manufacturer of Class III orthopedic implants needed to validate their manufacturing processes to meet FDA QSR requirements.
Solution by Bioexcel:
Outcome:
Challenge:
A multi-product facility struggled with inconsistent supplier quality, leading to delays in production and non-compliances.
Solution by Bioexcel:
Outcome:
Global Expertise
Proficient in ISO 13485, FDA QSR, EU MDR, and CDSCO requirements.
Tailored Solutions
Customized quality strategies for startups, SMEs, and large enterprises.
Proven Success
Extensive experience across diverse device categories, including Class III implants, diagnostic devices, and SaMD.
End-to-End Support
From QMS implementation to post-market compliance, we manage it all.
ISO 13485 is the international standard for medical device quality management systems, ensuring product safety, consistency, and regulatory compliance.
Internal audits should be conducted annually, while external audits are typically required for certification and regulatory inspections.
Yes, we provide quality and regulatory solutions tailored to meet the requirements of multiple regions, including the EU, US, and India.
Elevate the safety, reliability, and compliance of your medical devices with Bioexcel’s quality management and compliance services. Contact us today to build a solid foundation for regulatory success.
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