Solutions

• Regulatory Services: Assistance with FDA 510(k) clearances, CE marking, and compliance with international standards such as ISO 13485 and ISO 14971.
• Quality Management: Development and implementation of quality management systems, internal audits, and CAPA processes.
• Clinical Services: Support for clinical trial design, management, and regulatory submissions, including clinical evaluation reports.
• Engineering and Design: Medical device design, testing, and human factors engineering to ensure usability and safety.
• Testing and Validation: Comprehensive testing services, including biocompatibility, chemical, physical, and microbiological testing, ensuring your product meets regulatory standards.
• Cybersecurity and IT: Protecting your medical devices from cyber threats with risk assessments, data protection, and IT security solutions.
• Training and Education: Offering specialized training in regulatory compliance, quality management, and medical device development.

Our multidisciplinary team brings together expertise in engineering, regulatory affairs, clinical research, and quality management to deliver solutions that meet the highest standards. At B+solutions, we are committed to helping our clients achieve compliance, improve patient outcomes, and drive business success.