USA Regulatory ServicesWe provide comprehensive design and development documentation support to medical device organizations for establishing effective design controls and demonstrate conformity with ISO 13485 requirements.
Devices of class II, class III, and some of class I must comply with the requirements in Design and Development, Clause 7.3 and its Subclauses as per ISO 13485. The class I devices are as follows:
| Sr. No. | Section | Device |
|---|---|---|
| 1 | 868.6810 | Catheter, Tracheobronchial Suction |
| 2 | 878.4460 | Glove, Non-powdered Surgeon's |
| 3 | 880.6760 | Restraint, Protective |
| 4 | 892.5650 | System, Applicator, Radionuclide, Manual |
| 5 | 892.5740 | Source, Radionuclide Teletherapy |
Deliverables include:
• Design and development planning
• Design Input Documentation
• Design Review Documentation
• Design Output Documentation
• Design Verification
• Design Validation
• Design Transfer
• Design Change Management
• Design History Files
