Quality Assurance (QMS)
Ensure Quality from Day One
At Pelican MedTech, we support medical device companies in establishing and maintaining effective Quality Management Systems (QMS) and provide the services:
Full QMS implementation and maintenance, including documentation and SOPs.
Audit preparation (Mock FDA, ISO 13485, Notified Bodies).
CAPA process, Customer Complaint Handling,
Guidance in Design and Development: preparation of DHF (Design History File) including Hardware and Software.
Support with V&V, Process Validation, Risk Management, Transfer to Production.
Training your team on compliance and continuous improvement.
Integration of QMS, RM and ISMS.
Suport with MDR/IVDR certification.
