Stendard is now Live

Great news!

After almost two months of Stendard Beta program, we have listened to your comments and feedback on many ways to make our platform better. We have implemented them and is excited to announce that we are LIVE!

All of us in Stendard would like to thank everyone who have been with us in this journey this far. Rest assured that we will always continually improve our platform based on your feedback and include new features to provide the breeze to your compliance journey. Striving forward, we would like to welcome more businesses to adopt Stendard and start your first steps towards regulatory and compliance needs.

At the present moment, our platform is ISO 13485:2016 and US FDA 21 CFR friendly. If you are part of a medical device company in the following phase, Stendard is for you:

  • Involving in design and development of your medical device
  • Seeking your first ISO 13485 certification and/or US FDA 21 CFR compliance
  • Enthusiastically seeking certification in the next 3-5 months

If you have any concerns and questions (which we know you would), drop us a message here and we will arrange for a discussion session for each and every one of you. For those of you that would like to jump straight in and try Stendard out, click the button below to get started!

Stendard has been evaluated by international certification and industry groups to have met the requirements of ISO 13485:2016 and US FDA 21 CFR Part 820.