The links provided have proven to be useful in our daily routine of providing world-class support to our clients.
If there are additional resources or support, you need please do not hesitate to contact us.
We simplify procedures to focus on key documents and use a risk-based approach to focus on essential document content.
We provide traceability checklists to demonstrate how technical specifications align to applicable standards and regulations (FDA, ISO, IEC…)
Definition of quality system procedures based on the FDA Quality System Regulation and ISO 13485:2016 "Medical devices - Quality management systems".
We can tailoring our established procedure and templates to adjust to your practices.
Identifying vulnerabilities, risk, implementing controls, and testing.
Providing a Secure Product Development Framework (SPDF) in accordance with FDA Guidance.
Post-market Cybersecurity strategies and processes.
Process and Non-Product Software Validation
We have proven procedures, templates and checklists to assure that your manufacturing processes and quality support software remain in a defensible validated state.
We have processes, templates and checklists to assure that the risk management file for your device(s) remains defensible and supports your technical and regulatory filings.
We implement a practical approach to risk management to help your team be able to understand and own the process.
EU MDR and ISO 13485 Implementation
Our practical quality system solutions provide business value and assure compliance. These processes have tested and proven to be successful with leaders in the medical device and pharmaceutical industries.