Quick Tips: Comply to Standards

So how can you easily comply to standards as part of your medical device design and development process?

Script

Trying to be complaint to various standards?

Why not convert as much as the standard as possible into requirements?

That way, they are considered during the design stage, they can be used to mitigate risks, and they are evaluated as part of your test campaigns.

The result is a fully traceable report of the actions taken to determine compliance.

Links

If you are interested in which standards apply to your medical device, here are some handy links:

European Harmonised Standards

You can find a list of standards that are recognised by the European Commission.

(This was valid as of when this post was published, but may be updated in the future. Please check the EU website for the latest list.)

https://ec.europa.eu/growth/content/new-2020-lists-harmonised-standards-medical-devices-are-now-available_en

U.S. Recognised Consenus Standards

The F.D.A. publises a list of recognised standards in their database.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm

International Standards

Here you can find internationally recognised standards for sale. While these are the international versions, you may need to consider buying the standard that is relevant to your particular market instead.

International Standards Organisation (ISO)

https://www.iso.org/standards.html

International Electrotechnical Commission (IEC)

https://www.iec.ch/homepage

European Standards

This organisation prepares the international standards for the European market, making them relevant for devices operating within Europe. To purchase these, you should go to your relevant country and purchase the national standard there.

European Committee for Standardization (CEN)

https://standards.cen.eu/dyn/www/f?p=CENWEB:105::RESET::::

European Committee for Electrotechnical Standardization (CENELEC)

https://www.cenelec.eu/dyn/www/f?p=104:104:1657297817417301::::FSP_LANG_ID:25

U.S. Standards

This organisation prepares the international standards for the U.S. market, making them relevant for devices operating within the U.S.A.

American National Standard (ANS)

https://webstore.ansi.org/?_ga=2.46896224.653757045.1615796398-539843054.1615796398

Haylee Bosshard

Haylee is the CEO and founder of Conformify and has worked in the medical devices industry for a number of years. Haylee is on a mission to help companies to build effective, light-weight quality and regulatory processes that bring their medical device to market efficiently and with the highest quality.