- Our Approach to ISO 13485 Implementation
- Conduct QMS gap assessment for Audit readiness and certification
- QMS development and alignment with ISO 13485
- Providing Guidance on QMS implementation
- Conducting internal quality audits
- Providing training on QMS implementation
- Providing support for External Audit readiness
- Providing support for Post-Audit NC Closure & CAPA
- Annual QMS Maintenance
- Medreg will customize every Quality Management System for each organization based on their size, product type, risk class of device, manufacturing process, target market and regulatory requirements.
- Medreg will provide risk-based (by following ISO 14971:2019) decision-making approach to integrate daily operations which improve product quality and consistency.
- Medreg assist in developing quality plans for incoming materials, in-process materials, and finished products to establish appropriate inspection, testing, and acceptance criteria.
- Preparation of Required mandatory QMS Documentation
- Document the role(s) undertaken by the organization
- Written Quality Agreements with outsource suppliers
- Procedure for the Validation of the Application of Computer Software
- Quality Manual
- Quality Policy
- Quality Objectives
- Procedure for Document Control
- Procedure for Record Control
- Responsibilities and Authorities
- Procedure for Management Review
- Procedure for Competence, Training and Awareness
- Requirements for the infrastructure
- Requirements for the maintenance activities
- Requirements for the work environment
- Requirements for health, cleanliness and clothing of personnel
- Arrangements for the control of contaminated or potentially contaminated product
- Requirements for control of sterile medical device contamination
- Processes for risk management in product realization
- Arrangements for communicating with customers
- Procedure for Design and Development
- Procedure for Purchasing and Evaluation of Suppliers
- Procedure and methods for the control of production
- Requirements for cleanliness of product or contamination control of product
- Requirements for medical device installation and acceptance criteria for verification of installation
- Procedure for Servicing Activities of Medical Device
- Procedures for Validation of Processes
- Procedure for the Validation of Processes for Sterilization
- Procedure for Product Identification
- Procedure for Traceability
- Procedure for Preserving the Conformity of Product
- Procedure for Monitoring and Measuring Equipment
- Procedure for Customer Feedback
- Procedure for Complaint Handling
- Procedure for Internal Audit
- Procedure for Control of Nonconforming Product
- Procedure for Issuing Advisory Notices
- Procedure for Rework
- Procedure for Analysis of Data
- Procedure for Corrective Actions
- Procedure for Preventive Actions
- Medreg will assist to prepare templates for mandatory QMS records
- Quality Agreement with Outsourced Processes
- Records of Software Validation Activities
- Medical Device File
- Records of Management Review
- Records of Education, Training, Skills and Experience
- Records of the Maintenance Activities
- Records of Risk Management Activities
- Outputs of Product Realization Planning
- Records of the Results and Actions Arising from Review of Requirements Related to Product
- Records of Product Requirements Changes
- Design and Development Planning Documents
- Design and Development Inputs
- Design and Development Outputs
- Records of Design and Development Review
- Records of the Results and Conclusions of the Design and Development Verification
- Design and Development Validation Plans
- Records of the Results and Conclusion of Design and Development Validation
- Results and Conclusions of the Design and Development Transfer
- Records of Design and Development Changes
- Design and Development File
- Records of the Results of Evaluation, Selection, Monitoring and Re-evaluation of Supplier
- Records of the Purchased Product Verification
- Record for Each Medical Device or Batch of Medical Devices
- Records of Medical Device Installation and Verification of Installation
- Records of Servicing Activities
- Records of the Sterilization Process Parameters
- Records of the Results and Conclusion of Validation
- Records of the Results and, Conclusion of Sterile Medical Device Validation
- Records of Traceability
- Records of the distribution of medical device
- Records of the Name and Address of the Shipping Package Consignee
- Report to the Customer about Changes on his Property
- Records of the Results of Calibration and Verification of Monitoring and Measuring Equipment
- Records of the results and conclusion of process validation
- Customer Feedback Report
- Complaint Handling Records
- Records of Reporting to Regulatory Authorities
- Internal Audit Plan
- Internal Audit Report
- Evidence of Conformity of Products with the Acceptance Criteria
- Identity of the Person Authorizing Release of product
- Identity of Personnel Performing any Inspection or Testing of Implantable Medical Devices
- Record of Nonconformity
- Records of the Product Acceptance by Concession and the Identity of the Person Authorizing the Concession
- Records of Actions relating to the Issuance of Advisory Notices
- Records of Rework
- Records of the Results of Data Analysis
- Records of Corrective actions
- Records of Preventive actions
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