|Control of Documents
|Control of Records
|Management Review Meeting
|Design and Development
|Control of Production
|Identification and Traceability
|Advisory Notice and Recall
|Monitoring and Measuring Equipment
|Reporting to Regulatory Bodies
|Monitoring and Measuring of Product
|Control of Non-Conforming Product
|Customer Related Process and Distribution
The purpose of this procedure is to periodically review QMS implemented at the company and access opportunities for improvement, review the company’s quality policy and quality objectives at planned intervals to ensure continuous suitability, adequacy, and effectiveness.
The procedure and formats are prepared as per the requirements of ISO 13485:2016, this template will help in gauging a company’s QMS especially when applying for certification or maintaining compliance with QMS in day-to-day activities. This template is written specifically for early-stage medical device companies, is audit-ready, and is written by highly experienced professionals.
The purpose of this procedure is to document processes for the recruitment of personnel, Determine and establish the necessary competence of employees, to identify the training needs, and provide training effectively to ensure that all the employees have the necessary knowledge and skills to carry out their activities and to evaluate the effectiveness of the training.
The procedure is written for compliance with ISO 13485:2016 and applicable regulatory requirements and is simplified for easy and hassle-free implementation. This template is written specifically for early-stage medical device companies, is audit-ready, and is written by highly experienced professionals.
The purpose of this procedure is to define the company’s risk management process.
This risk management procedure pertains to the entire product realization process from the beginning of design and development through obsolescence. The procedure is compliant with ISO 13485:2016, ISO 14971:2019, ISO/TR 24971:2020 and applicable regulatory requirements. This procedure is the primary document meeting the applicable regulatory requirements for risk management as defined in Company’s Quality Manual. This 15 pages Template of risk management procedure provides you the information regarding the risk analysis process, evaluate the risk, risk estimation, risk control, Residual Risk Evaluation, Benefit-Risk Analysis, etc. This template is written specifically for early-stage medical device companies, are audit ready, and are written by highly experienced professionals.