Ensure Quality from Day One. We support medical device companies in building robust Quality Management Systems (QMS) that not only meet regulatory requirements but also drive operational excellence.
Our expert team guides you through every step of your quality journey, ensuring compliance and efficiency.
End-to-end implementation and maintenance, including documentation and Standard Operating Procedures (SOPs).
Comprehensive prep for Mock FDA audits, ISO 13485 certification, and Notified Body assessments.
Robust CAPA processes and Customer Complaint Handling to ensure continuous improvement and safety.
Guidance in Design and Development, including preparation of Design History Files for Hardware and Software.
Support with Verification & Validation, Process Validation, and Risk Management (ISO 14971).
Expert support with navigating the complexities of MDR and IVDR certification processes.