TF & QMS
...make it simple and effective!
Technical File (TF)
To obtain the CE marking for a medical device, it is essential to prepare a technical dossier, Technical File, containing detailed and updated information about the product or family of products that justifies a design and manufacturing consistent with the regulation plus a quality system (QMS) that justifies continuity over time.
From MeDev Consulting, we prepare complete TFs for presentation to Notified Bodies (NB).
Technical File Content
The TF must contain the necessary documents to comply with all regulatory requirements (MDR 2017/745):
- Intended use and mode of operation
- Product identification and risk class
- Novel features and accessories
- Technical specifications
- Packaging, labels and instructions for use
- Design stages
- Manufacturing and validation processes and locations
- Critical suppliers and subcontractors
- Methods to demonstrate safety and performance
- Directives, regulations and harmonized standards
- Benefit/risk analysis
- Adopted solutions
- Preclinical and clinical data
- Biocompatibility, electrical safety, EMC
- Stability, shelf life, performance
- Clinical evaluation and post-market clinical follow-up (PMCF)
Quality Management System (QMS)
The quality management system includes planning, controlling and improving those elements that influence customer satisfaction and the achievement of desired results.
To achieve CE marking, it is essential to develop and implement a standardizable quality system.
From MeDev Consulting, we design, implement and achieve certification under ISO 13485.
QMS Structure
Define policies, objectives and guidelines for the achievement of quality and customer satisfaction aligned with desired results.
Determine, analyze and implement the required processes and procedures, with monitoring and control activities.
Define assignments of personnel, equipment and machinery necessary for production, work environment and financial resources.
Define responsibilities, authorities and communication flow within the organization.
Establish procedures, forms, records and documentation for the effective operation of processes.
Include specific regulatory requirements under MDR (EU) 2017/745 for medical devices.