My expertise in quality and regulatory compliance can help you prepare for and survive your next ISO or GMP Audit. I can also help implement a QA system that will help your business run more smoothly and efficiently.
Quality Assurance and Compliance Services RedEdge Consulting is committed to helping clients find the most cost-effective method for achieving quality goals and regulatory compliance. By working closely with my clients, I can design, implement, and evaluate the systems and documentation necessary to meet U.S. FDA Quality System Regulation, ISO standards, European Medical Device Directives, and Canadian Medical Device Regulations. RedEdge Consulting's comprehensive quality assurance and compliance services include:	Regulatory Services RedEdge Consulting provides strategic planning for new product introductions and expert planning, management, and preparation of regulatory submissions. I can offer an in-depth knowledge of FDA medical device regulations and policies. I can assist both small and large companies in meeting these regulations and requirements. RedEdge Consulting provides the following comprehensive services for all aspects of regulatory affairs:
Developing and implementing Quality Systems to comply with QSR, ISO 13485, ISO 9001 Consulting on Regulatory Compliance Issues Developing and Implementing Process Validation Programs Perform regulatory GAP analysis and mock FDA inspections Conduct internal audits Supplier selection/qualification Compliance Program Development, Implementation and Training GMP/Quality System Regulation expertise Complaint management Corrective Action Implementation	Device Classification and Pre-market Strategy Developing and Implementing Regulatory Strategies Provide FDA Regulatory Strategy for device development, pre-market submission, and FDA review Prepare or assist with 510(k)s, Investigational Device Exemptions (IDE), and Pre-market Approval (PMA)submissions Technical Dossiers (files) for CE Mark Developing and Review Instruction Manuals and Other Labeling for FDA Compliance FDA 483 and Warning Letter Recovery Medical Device Reporting Recall Coordination Post-market Requirements