Medical Device Technical Documentation for MDR means a set of documents demonstrating a specific product’s compliance with the relevant CE marking legislation. The documentation must indicate the applicable product safety standards and requirements and cover the product’s design, manufacture, and operation.
Medical Device Technical Documentation for MDR
The technical Documentation or dossier includes detailed information about the design, function, , use, claims, material of construction and clinical evaluation of your medical device.They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein. Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical File must be reviewed by a Notified Body. Understanding how to assemble this information and present it for review by Notified Bodies is essential.
MDR Technical Documentation
QA and Regulatory team members are always confused or find it difficult in identifying the required number of medical device technical files for the products planned for European CE Marking.It is advised to remember that medical device technical file or documentation is all about your device to establish safety and performance. It means you cannot combine products with the different intended use, or different class, or different construction material, or even different design.
Medical Device Technical File
- Requirement & Identification as per CE MDR
- Risk classification and identification of assessment route of CE Marking
- General Safety and performance requirement evaluation.
- Systmatically organize and arrange Files and review.
- Clinical Evaluation documentation covering PMS, PMCF & PSUR
- Risk Analysis
- Medical Device Quality Management System Implementation
Contact details –
Phone no - 9325283428Mail - dm@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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