Design & risk
Requirements, usability, risk management and verification planned from development.
QUALITY ASSURANCE
Quality is designed in.
Our quality framework connects product development, suppliers, production and post-market learning across the device lifecycle.
QUALITY MANAGEMENT SYSTEM
Controlled from concept
to customer.
ISO 13485 provides the framework. Documented decisions, trained people and traceable records make it operational.
QUALITY FRAMEWORKISO
13485PRODUCT LIFECYCLE
13485PRODUCT LIFECYCLE
Supplier control
Components evaluated through qualification, incoming inspection and change management.
Process control
Documented instructions, calibrated equipment and in-process checks support consistency.
Product release
Final inspection and device history records provide traceability for every released lot.
Post-market
Feedback, complaints and CAPA connect field experience to continuous improvement.
U.S. MARKET READINESS
Regulatory status,
stated clearly.
FDA establishment registration, device listing and premarket authorization are different concepts. We evaluate the applicable pathway for the specific product and market, and provide verified documentation during commercial review.
Request regulatory information