Medical Device Manufacturers must establish current Good Manufacturing Practices to ensure marketed devices meet applicable regulatory, quality requirements meeting the specifications. CGMP requirements for devices are covered in 21 CFR 820. FDA 21 CFR part 820 Requirements is similar to ISO 13485 – Medical Device Quality Management System Requirements.
The GMP / QS 21 CFR Part 820 applies to finished device manufacturers who intend to commercially distribute medical devices in the USA market.
Medical Device Manufacturers must establish current Good Manufacturing Practices to ensure marketed devices meet applicable regulatory, quality requirements meeting the specifications. CGMP requirements for devices are covered in 21 CFR 820. 21 CFR part 820 Requirements is similar to ISO 13485 – Medical Device Quality Management System Requirements.
The GMP / QS 21 CFR Part 820 applies to finished device manufacturers who intend to commercially distribute medical devices in the USA market.
|
21 CFR 820 |
ISO 13485 |
| § 820.1 – Scope. | 1 Scope
2 Normative References |
| § 820.3 – Definitions. | 3 Terms and Definitions |
| § 820.5 – Quality system. | 4 Quality Management System
4.1 General Requirements 4.2 Documentation Requirements |
| Subpart B–Quality System Requirements | |
| § 820.20 – Management responsibility.
|
5.0 Management Responsibility |
| § 820.22 – Quality audit.
|
8.2.4 Internal Quality Audits |
| § 820.25 – Personnel. | 6 Resource Management |
| Subpart C–Design Controls | |
| § 820.30 – Design controls. | 7.1 Planning of Product Realization
7.2.1 Customer Related Processes 7.2.2 Review of Requirements Related to Product 7.3 Design and Development |
| Subpart D–Document Controls | |
| § 820.40 – Document controls. | 4.2.4 Control of Documents |
| Subpart E–Purchasing Controls
|
|
| § 820.50 – Purchasing controls. | 7.4.1 Purchasing Process
7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product |
| Subpart F–Identification and Traceability | |
| § 820.60 – Identification | 7.5.8 Identification |
| § 820.65 – Traceability. | 7.5.9 Traceability |
| Subpart G–Production and Process Controls | |
| § 820.70 – Production and process controls. | 6.2 Human Resources
6.3 Infrastructure 6.4 Work Environment and Contamination Control 7.5.1 Control of Production and Service Provision 7.5.6 Validation of Processes for Production and Service Provision |
| § 820.72 – Inspection, measuring, and test equipment. | 7.6 Control of Monitoring and Measurement Equipment |
| § 820.75 – Process validation. | 7.5.6 Validation of Production and Service Provision |
| Subpart H–Acceptance Activities | |
| § 820.80 – Receiving, in-process, and finished device acceptance. | 7.1 Planning of Product Realization
7.4.3 Verification of Purchased Product 7.5.1 Control of Production and Service Provision |
| § 820.86 – Acceptance status. | 7.5.8 Identification |
| Subpart I–Nonconforming Product | |
| § 820.90 – Nonconforming product. | 8.3 Control of Nonconforming Product |
| Subpart J–Corrective and Preventive Action | |
| § 820.100 – Corrective and preventive action. | 8.5.2 Corrective Action
8.5.3 Preventative Action |
| Subpart K–Labelling and Packaging Control | |
| § 820.120 – Device labelling. | 4.2.3 Medical Device File
7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.130 – Device packaging. | 4.2.3 Medical Device File
7.5.8 Identification 7.5.11 Preservation of Product |
| Subpart L–Handling, Storage, Distribution, and Installation | |
| § 820.140 – Handling. | 4.2.3 Medical Device File
7.1 Planning of Product Realization 7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.150 – Storage. | 4.2.3 Medical Device File
7.1 Planning of Product Realization 7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.160 – Distribution. | 4.2.3 Medical Device File
7.1 Planning of Product Realization 7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.170 – Installation | 4.2.3 Medical Device File
7.5.3 Installation Activities 7.5.8 Identification 7.5.11 Preservation of Product |
| Subpart M–Records | |
| § 820.180 – General requirements. | 4.2 Documentation Requirements
4.2.3 Medical Device File 7.1 Planning of Product Realization |
| § 820.181 – Device master record. | 4.2.3 Medical Device File |
| § 820.184 – Device history record. | 4.2.5 Control Records
7.1 Planning of Product Realization 7.5.8 Identification |
| § 820.186 – Quality system record. | 4.2 Documentation Requirements
7.1 Planning of Product Realization |
| § 820.198 – Complaint files | 7.2.3 Communication
8.2.1 Feedback 8.2.2 Complaint Handling 8.2.3 Reporting to Regulatory Authorities |
| Subpart N–Servicing | |
| § 820.200 – Servicing | 4.2.3 Medical Device File
7.1 Planning of Product Realization 7.5.4 Servicing 7.5.8 Identification |
| Subpart O–Statistical Techniques | |
| § 820.250 – Statistical techniques. | 8.1 General
8.4 Analysis of Data |
Refer ISO 13485 Section for more details
We will respond to you within one working day.