Product compliance
ISO 13485
Medical Devices Quality Management System
The quality system regulators and notified bodies expect from medical device manufacturers and their suppliers.
Typical timeline
Typically 5 to 7 months.
What you end up with
A device quality system that supports market approval, not just a certificate on the wall.
Who it applies to
Is this your situation?
Device manufacturers, contract manufacturers and sterilisation or packaging suppliers in the device chain.
01Device and IVD manufacturers
02Contract manufacturers and component suppliers
03Packaging and sterilisation service providers
How we help
What we actually deliver
Design control, risk management to ISO 14971, validation, traceability, complaint handling and post-market surveillance build-out.
▪Design and development control file structure
▪Risk management file to ISO 14971
▪Process validation and traceability system
▪Complaint, vigilance and post-market surveillance process
Often held together