We can help you to establish and maintain your Quality Manual and Document Control Systems to a number of recognized models, including:
- Current Good Tissue Practice Regulations (21 CFR 1271)
- Quality System Regulations for Medical Devices (21 CFR 820)
- American Association of Tissue Banks – Standards for Tissue Banking
- Eye Bank Association of America – Procedures Manual and Medical Standards
- ISO 9001:2000 – Quality Management Systems – Requirements
- ISO 13485:2003 – Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Development of Document and Data Control Systems (Change Control), including installation and configuration of electronic change control systems
Technical Writing and Training, including:
- Quality Manual – Quality Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Product Specifications
- Process Specifications