Medical devices
Instruments, implants, software and diagnostics used in care.
Overview
Instruments, implants, software and diagnostics used in care. It sits within healthcare and carries both general healthcare obligations and its own specific rules.
Device makers must classify each device by risk, obtain the right approval or certification for each market, run a quality management system and report adverse events.
Authorities in this glossary active in it include FDA, Health Canada and MHRA. It sits within healthcare.
Check the official sources below for legal scope, applicable dates and exceptions. This entry is an explanatory reference, not legal advice.
Why it matters
Regulators increasingly look at activities and outcomes in this space, so obligations follow the business model rather than the label.
Who it affects
Organisations operating in medical devices, and the vendors who serve them.
Where it sits
Ten linked steps connect where you operate to the proof that you complied.
- 01Jurisdiction
- 02Industry
- 03Activity
- 04Authority
- 05Regulation
- 06Requirement
- 07Guidance
- 08Control
- 09Evidence
- 10Enforcement
Hierarchy
- Part of
- Healthcare
- Members & authorities
- FDAHealth CanadaMHRA
Connections
The terms most closely tied to Medical devices. Select one to open it.
What to do about it
- 1List the activities you actually perform.
- 2Identify the authorities and licences those activities trigger.
- 3Scope your obligation library to the sector and its activities.
- 4Set up controls and evidence for the highest-risk obligations first.
From requirement to evidence.
Tag your organisation with this sector and Regulation Layer scopes the obligation library to it.
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