Quality is everything when it comes to medical devices. Regulatory authorities require it, physicians expect it, and patients depend on it. Establishing a comprehensive quality management system and quality products help you build a reputation of integrity with your customers that will result in repeat business. Because of the proliferation of standards and quality management system requirements worldwide, maintaining a good quality management system and ensuring the continued quality of your products can prove to be a difficult task.
Our experienced team knows and understands the ever-changing global quality and compliance requirements and has significant experience creating quality management systems that comply with FDA regulations, as well as those of the European Union, Japan, Korea, Brazil, Australia, and Canada. Our team is able to ensure your product(s) is designed to comply with ISO 13485 and applicable product safety standards. Fang will support you in establishing the quality management system and quality products you need to prevent deficiencies and product recalls.
Quality and Compliance capabilities include, but are not limited to:
- Quality Management System (QMS) Development & Support
- Selection and Interpretation of US and International QMS Requirements
- Drafting ISO 13485 Quality Manuals and Procedures
- ISO 13485 Auditing
- Conducting Gap Analyses, Pre-audits, and Internal Audits
- Assessing Applicable Product Safety Standards and Developing Product Safety Test Protocols
- EU MDR / MDD Compliance
- Developing Medical Device Reporting (MDR) and European Vigilance Reporting Systems
- Managing QMS for virtual companies
- Communications for Product Field Actions (Safety Alerts, Product Recalls, Corrective Actions)
- Change Orders
Developing Quality Management Systems (QMS) that Comply with the FDA Regulations, as well as the European Union, China, Japan, Australia, Canada, etc.