Quality Management System
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At B+solutions, we prioritize quality in every step of the medical device development and manufacturing process. Our Quality Management Services are designed to help companies establish, maintain, and continuously improve their Quality Management Systems (QMS) to comply with international standards and regulatory requirements. We provide comprehensive support in the following areas:
• Quality System Development and Implementation (e.g., ISO 13485): We assist in designing and implementing a tailored QMS that meets the requirements of ISO 13485, ensuring your processes are optimized for quality and regulatory compliance.
• Quality Audit and Compliance Services: Our team conducts thorough internal audits to identify gaps and areas for improvement, helping you achieve and maintain compliance with industry regulations.
• CAPA (Corrective and Preventive Action) Implementation: We support the development and implementation of effective CAPA processes to address non-conformities and prevent future issues.
• Risk Management and FMEA (Failure Mode and Effects Analysis): We help you identify and manage potential risks throughout the product lifecycle, ensuring the safety and reliability of your devices.
• Supplier Quality Management: We assist in evaluating and managing suppliers to ensure that the materials and components used in your products meet quality standards.
• Internal Audit and Training: We provide training and internal audit services to prepare your team for regulatory inspections and ensure ongoing compliance.
• ISO 13485:2016 Audit and Certification: Our experts guide you through the audit process to achieve ISO 13485 certification, demonstrating your commitment to quality.
• MDSAP (Medical Device Single Audit Program) Audit: We help prepare for MDSAP audits, allowing for regulatory recognition across multiple jurisdictions, including the U.S., Canada, and Australia.
With B+solutions as your partner, you can be confident that your Quality Management System will not only meet regulatory standards but also drive continuous improvement and operational excellence. Let us help you navigate the complexities of quality management and achieve lasting success.