From ISO 13485 to IEC 62304, these standards define what it takes to bring a safe medical device to market. We help you understand them, implement them, and pass your audit.
These are the five core standards every medical device manufacturer needs to understand, regardless of target market. They are universally recognized across EU, UK, USA, Australia, New Zealand, and Asia, and form the backbone of any successful regulatory submission.
Core Standards
Click on each standard to learn what you need to know, where it applies in your journey, and how we support you.
The foundation for everything. ISO 13485 defines how a Quality Management System must be built for medical device companies. Without certification, you cannot sell in most markets.
Before any device reaches the market, its risks must be systematically identified, evaluated, and controlled. ISO 14971 is the global standard for doing this right.
If your product includes software, or is software, IEC 62304 defines the lifecycle processes required for safe development, maintenance, and risk management of medical device software.
Incorrect use is one of the most common causes of medical device incidents. IEC 62366 ensures your device can be used safely and effectively, even under stress or by untrained users.
Every device that contacts the human body, skin, blood, or tissue, must prove it causes no harmful reactions. ISO 10993 defines which tests are required and how to interpret them.
How We Help
We don’t just explain the standards, we implement them with you, end to end.
We analyze which standards apply to your device, classification, and target markets, and where you currently stand.
We build the required processes, documentation, and evidence into your QMS, practical, lean, and audit-ready.
We support you through the audit, close findings, and stay onboard for surveillance and recertification cycles.