The pslove company
Founded in 2014, this Singaporean startup based in BLOCK71 Singapore has been "saving" thousands of women every month. While many know them as the creator behind MenstruHeat, the 100% natural heat therapy patch that can produce long lasting heat when applied to the abdomen area, little is known about what goes on behind the scene - in order to get this product from design & development to the shelves near you.
We first got to know the founders of the pslove company in BLOCK71 (we're neighbours!) and got to know of their difficulties in navigating the regulatory landscape of GDPMDS (Layman: the standard for distributors in the medical device space). Only recently, Peck Ying and Caleb shared with us a great piece of news - they are expanding into the regional markets!
While expansion is always good news to every organisation, expanding in the medical device market comes at a greater commitment: the ISO 13485. We took this opportunity to hear what Tan Peck Ying and Caleb Leow (both co-founders of the pslove company) has got to share about their love and hate towards ISO 13485.
Largest obstacles in ISO 13485
"Mainly the huge paperwork and being clueless about the unknowns ahead. We know that the ISO 13485 has a lot more requirements and definitely needed help", said Caleb. With a little homework, both of them quickly learnt that there are 2 main ways to obtain ISO 13485 now:
1) Purchase a set of ISO 13485 template library
2) Hire a consultant to cover from document creation, to training and implementation
While the first method is fairly affordable, it provides too much room for error especially for first-timers. The second method is naturally pricier and budget constraint is the most crucial concern for the company at the moment. Caught in this dilemma, Caleb and Peck Ying have plans for the company to begin attending online courses about ISO 13485 certification and take the self-serve approach towards attainment of ISO 13485.
Existence of Stendard First™
As the name implies, Stendard First™ is designed to enable companies to quickly and effectively create their set of ISO 13485:2016 documentation (more than 70 documents, to be exact). Using a Q&A based interface, the smart generator is able to filter, recommend and create a set of document close to every individual organisation.
"When we first tried Stendard, we were honestly very impressed as we didn't expect to finish the entire process in less than half a work day", pointed by Peck Ying.
That day, they found out the coverage and requirements of ISO 13485:2016 were shockingly huge. "Comparing to GDPMDS, the ISO 13485:2016 is so much more in-depth, and we are glad that we finally know the depth of coverage and our team members felt so much more confident handling it now", mentioned Caleb.
"With Stendard First™, we are able to bring companies from ground zero in compliance to a good level of knowledge and allow the companies to work with a customised set of ISO 13485 documents", shared Jason Lim, CEO of Stendard.
But work is not completed yet, because Stendard is currently working with our close partners to form bundle packages and allow companies to enjoy a range of value-added services. These includes, but not limited to:
1. Online training courses for ISO 13485:2016
2. Internal auditor training classes
3. Advisors to provide customised training programme and implementation
4. Transition advisors from ISO 13485:2003 to ISO 13485:2016
5. ISO 13485:2016 Certification with renown Notified Bodies
Every year, among the 38,000 ISO 13485:2016 certifications issued worldwide, there are many just like the pslove company, who felt confused and unsure of what to expect. One word of advice, try out Stendard First™.
P.S. It's free until you have the confidence in the ISO 13485:2016 documentation, or if you are ready to steam ahead towards your certificate. Whichever way, that's what Stendard First™ is designed for.
Enjoy staying complaint!