Quality Assurance
Our quality management process
At NOVO, our process follows the highest development standards from the very beginning of the project until your certification, and this is across all our teams. With our ISO 13485:2016 certification, you can have the peace of mind that our development process follows the regulatory standards and requirements.
- Quality Management and planning
- Risk Management
- Documentation
- ISO 13485:2016 Certification
- Regulatory compliance for the United States, Canada, and Europe
By collaborating with NOVO for your product development, our QA team can support you with:
Development standards and their implication
Standards are not always very easy to implement and understand for startups and businesses that are newly subjected to them. Our team can support you in order to familiarize yourself with the standards for the development of a medical product, or simply to follow good practices and be familiar with the constraints associated with them.
- ISO 13485:2016
- ISO 14971:2012
- IEC 62304:2006/AMD 1:2015
- IEC 60601-1 ed.3.1
- IEC 62366-1:2015
Documentation
The quality assurance team offers the client a documentation framework to meet the high standards of medical product development.
- Identify documentary deliverables
- Provide documentation templates
- Redact the documentation (plans, reports, etc.)
- Review the documentation
- Manage document reviews and approvals
- Ensure the traceability of documents
The planning of activities required by standards
The quality assurance team provides assistance in the high-level planning of development activities required by medical standards.
- Identify the required activities for medical product development
- Identify the inputs and outputs at every step of the way
- Determine the order of execution of activities
- Estimate the efforts and time required to complete the activities
Risk management
Risk management is an important factor in medical product development. The quality team ensures that analysis and risk management activities are carried out throughout the development process.
Take your product development to the next level with our quality assurance team.
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