Glossary key term references are listed below.
Key Term References
There are currently 21 references in this directory beginning with the letter I.
- US (FDA and OLRC) regulations, US FDA guidance documents, European (EU) regulations, and IMDRF documents are available online for free.
- International (ISO and IEC) standards are available for purchase from ISO or IEC, and in some cases, a preview or read-only version may be available online for free.
- American (US) versions of international medical device standards are available for purchase from AAMI which offers significant discounts for AAMI members.
- Other national versions of international standards are available for purchase from national standards bodies.
For an introduction to medical device standards and regulations, view online video Course 250 – Regulatory Compliance.