Important Standards in Medical Device Manufacturing
There are several important standards for compliance in medical device manufacturing.
IEC 62304
IEC 62304 specifies lifecycle requirements for medical devices and medical device software.
ISO 14971
ISO 14971 is the risk management standard for medical devices.
ISO 13485
ISO 13485 specifies the quality management requirements for medical devices.
FDA Regulations
Several FDA regulations are also applicable to medical devices, including 21 CFR Part 11.
European Medical Device Directives
European Medical Device Directives are required for selling medical devices in the European Union. Compliant devices receive a CE Mark.
Medical Device Testing and Development Tools
Medical device developers count on Perforce tools for compliance.
Helix Core is version control software. You can use Helix Core to securely version all digital assets — from medical device designs to embedded code. Helix Core tracks every change ever made and integrates with Helix IPLM and Helix ALM, too.
Why Use Perforce’s Medical Device Development Tools?
Perforce’s medical device development tools are best-in-class. So, you can…