Quality Management Systems, Regulatory Affairs and Product Lifecycle Management for Medical Device Companies
Introduction
In order to reach the commercialization stage of a medical device, companies need to implement the following three processes:
These areas are interrelated. The procedures defined in the QMS drive the lifecycle of the product. In practical terms, the implementation of areas 1 and 2 must run in parallel and planned in a way that the company documentation and staff are ready and available to perform the work efficiently and correctly. Once the product is internally released, applications to regulatory bodies (e.g., FDA, Health Canada, CE) will be submitted to get clearance for product marketing.
1. Quality Management System & Regulatory Affairs
The implementation of a Quality Management System and Regulatory Affairs consist on the creation, inspection and approval of Standard Operating Procedures (SOPs), Work Instructions, forms and templates.
Normally, 90 to 120 documents are part of the QMS. The documents will be produced and organized according to chapters of ISO 13485:2016:
Formal Training: Training must be provided for all the delivered Standard Operating Procedures and related work instructions, forms and templates.
2. Product Lifecycle Management
Product Lifecycle Management (PLM) is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service, maintenance and disposal.
The product may include both hardware and software. The product development process consists on documenting and translating the product requirements into working hardware and executable software. This is accomplished by applying consistent and recognized product development practices and providing adequate supporting documentation for requirements traceability, project communication, reviews, validation, hazard analysis, and applicable regulatory compliance.
The product development process generally consists of the following phases:
However, it is very important to emphasize that the type of development process (Waterfall, Spiral, Iterative, Agile, etc.) will determine how and when the documentation, working hardware, executable software and test results are delivered. The details of the selected development process will be defined in the Development Plan.
The activities and deliverables throughout the lifecycle of the product should be compliant with FDA regulations, ISO 14971:2007 (Medical Devices - Risk Management - Part 1: Application of Risk Analysis), ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes), IEC 62304:2006 (Medical device software - Software life cycle processes) and other regional standards and regulations.
3. Submission to Regulatory Bodies
Once the product is internally released and the QMS training is completed, applications to regulatory bodies (e.g., FDA, Health Canada, CE) will be submitted to get clearance for product marketing. The submission contents will depend on the Risk Analysis of the product. The QMS and product lifecycle process offered are designed to satisfy all the requirements of the regulatory bodies.
Services Provided
Hector Guestrin provides:
In order to reach the commercialization stage of a medical device, companies need to implement the following three processes:
- Quality Management System & Regulatory Affairs (QMS & RA)
- Product Lifecycle Management (PLM)
- Submission to Regulatory Bodies
These areas are interrelated. The procedures defined in the QMS drive the lifecycle of the product. In practical terms, the implementation of areas 1 and 2 must run in parallel and planned in a way that the company documentation and staff are ready and available to perform the work efficiently and correctly. Once the product is internally released, applications to regulatory bodies (e.g., FDA, Health Canada, CE) will be submitted to get clearance for product marketing.
1. Quality Management System & Regulatory Affairs
The implementation of a Quality Management System and Regulatory Affairs consist on the creation, inspection and approval of Standard Operating Procedures (SOPs), Work Instructions, forms and templates.
Normally, 90 to 120 documents are part of the QMS. The documents will be produced and organized according to chapters of ISO 13485:2016:
- Quality Management System (Chapter 4)
- Management Responsibility (Chapter 5)
- Resource Management (Chapter 6)
- Product Realization (Chapter 7)
- Measurement, Analysis and Improvement (Chapter 8)
Formal Training: Training must be provided for all the delivered Standard Operating Procedures and related work instructions, forms and templates.
2. Product Lifecycle Management
Product Lifecycle Management (PLM) is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service, maintenance and disposal.
The product may include both hardware and software. The product development process consists on documenting and translating the product requirements into working hardware and executable software. This is accomplished by applying consistent and recognized product development practices and providing adequate supporting documentation for requirements traceability, project communication, reviews, validation, hazard analysis, and applicable regulatory compliance.
The product development process generally consists of the following phases:
- Project Planning and Requirements Definition
- Project Planning and Design
- Product Risk Analysis
- Implementation
- Validation
- Release
- Service & Maintenance
However, it is very important to emphasize that the type of development process (Waterfall, Spiral, Iterative, Agile, etc.) will determine how and when the documentation, working hardware, executable software and test results are delivered. The details of the selected development process will be defined in the Development Plan.
The activities and deliverables throughout the lifecycle of the product should be compliant with FDA regulations, ISO 14971:2007 (Medical Devices - Risk Management - Part 1: Application of Risk Analysis), ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes), IEC 62304:2006 (Medical device software - Software life cycle processes) and other regional standards and regulations.
3. Submission to Regulatory Bodies
Once the product is internally released and the QMS training is completed, applications to regulatory bodies (e.g., FDA, Health Canada, CE) will be submitted to get clearance for product marketing. The submission contents will depend on the Risk Analysis of the product. The QMS and product lifecycle process offered are designed to satisfy all the requirements of the regulatory bodies.
Services Provided
Hector Guestrin provides:
- QMS Documentation Packages
- QMS Training
- Management and support for all the processes described above.