The criticality of the development, implementation, adherence and continuous improvement of a compliant Quality Management System (QMS) cannot be overstated. Not only are these key processes in driving company value, but more importantly, they help ensure patient safety and the delivery of high-quality products to those that need them most.

BIOMEDISCA offers comprehensive support to medical device manufacturers in the areas of U.S. FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR) and ISO standards compliance. Our global medical device Quality Team has supported organizations ranging from Fortune 100 to small start-ups, and many have worked directly for a variety of device Sponsors and global regulatory and compliance entities. This expertise and experience allows our team to uniquely tailor medical device quality systems to the specific needs of each manufacturer, their products and culture.

BIOMEDISCA’s global Quality Team can assist you efficient, cost-effective activities such as:

• Audits and Gap Assessments to: FDA 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485 and ISO 9001 Standards, Medical Device Regulation 2017/745 (MDR) and Medical Device Single Audit Program (MDSAP)
• Assistance in resolving gaps identified
• Change Control and Corrective and Preventive Action (CAPA), including Root Cause Analysis
• Design Controls: Review / assess existing procedures and records, develop and implement full design control procedures, processes and records
• Design History File development or Gap Assessment
• Device Master Record (DMR) development or Gap Assessment
• Health Hazard Evaluation (HHE)
• Internal audits
• Pre-BIMO/Mock BIMO inspections
• Process validation
• Quality system development and implementation to: FDA 21 CFR 820 (QSR), ISO 13485, ISO 9001 and Medical Device Regulation (MDR)
• Quality system mock inspections: U.S., EU, China, Japan
• Quality system remediation
• Risk Management Program: Review / assess existing procedures, plans, reports and records; develop and implement plans, risk analyses and reports
• Standards assessments
• Supplier audits

Our audit services are designed to help you identify areas for improvement and ensure compliance with regulatory requirements. We can conduct internal audits to identify non-conformances and areas for improvement, helping you to address any issues before they become bigger problems. Our team can also prepare for and participate in regulatory audits, helping you to navigate the audit process and demonstrate compliance to regulatory authorities.