After ISO 13485, what's next for Stendard?

Hint: We're heading back home to Singapore.


Our Humbling Experience

Since our launch of Stendard First™ in Sept 2017 (6 months ago), Stendard has impacted more than 100 companies all over the world. This equates to more than 23400 man-hours slashed off the documentation journey, saving our clients a total of more than USD 3,510,000.

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For that, we are thankful for all our clients' support. As promised, we will keep expanding our offerings to enable more companies, to allow your products a further reach, and to pay lesser for more.

So what's next for us at Stendard?

Back home to Singapore

While we have done much to help medical device product owners meet ISO 13485 (and we will continue to do so), we are constantly curious and always on the lookout for other areas where we can do our part as well.

We started asking ourselves:

  1. Which sector impacts Singapore consumers the most?
  2. What regulations are in place to control import/export of said products in Singapore?
  3. How can we help Singapore companies overcome this challenge?

If you are familiar with the Singapore regulation, the answers should be easy:

MEDICAL DEVICES. SS 620. Stendard First™.

This led us to our next journey.

Singapore Standard SS 620:2016

The Singapore Standard SS 620:2016 – Good Distribution Practice for Medical Devices - Requirements was developed by SPRING Singapore (now Enterprise Singapore) under the Singapore Standardisation Programme.

If you are storing, trading and distributing medical devices, you would have probably heard of the Good Distribution Practice (GDP) before. While it differs slightly between different countries, it usually serves as a guide for the handling, storage, delivery, installation, servicing, secondary assembly and other related activities (for example, warehousing, logistics and freight forwarding services) of medical devices, including in-vitro diagnostic devices and software.

Prior to SS 620:2016, the Good Distribution Practice for Medical Devices was also known as the HSA GDPMDS. With its new rollout, Stendard First™has created a smart generator to help companies adhere to the SS 620:2016 quickly and easily.

Stendard First™

If you had the opportunity to try our ISO 13485 smart generator, the way SS 620:2016 will work is exactly the same. We have digested the entire documentation requirements into 4 simple steps:

  1. Fill in company information,
  2. Answer the Q&A to generate your Site Master File,
  3. Answer the Q&A to generate each procedure recommended by our algorithm,
  4. Review/Edit the documents and export them in a single click.

We are excited to announce that the SS 620 module is going to be released in less than a month. For now, there's no formal announcement regarding the price for the module - which means we will keep it free for a limited time period.

However, we expect that the request is going to be overwhelming and we would prefer to give our users a well-guided experience throughout this period. As such, the SS 620 accounts are by-invitation only.

The Invitation

If you would like to request for an invitation by our team, we have created a short form to be filled. You can find it through the button below:

We remain committed in making sure that your compliance journey is well taken care of, and if there's any feedback for our team to improve on or to support you better, please feel free to contact us.

If not, we will see you within the Stendard First™ platform! Enjoy staying compliant!

 

Yours sincerely,

Mr Jason Lim
CEO and Co-founder of Stendard