Breaking the ISO 13485 barrier towards clinical usage - MagnePath (Australia) x Stendard

MagnePath Pty Ltd (Perth, Australia)

MagnePath Pty Ltd is a digital health company, with foundations in medical imaging. By inventing the next generation of body analytics to map the health of the human body, their goal is to put a true picture of your health in the palm of your hand.

We had the opportunity to catch up with the CTO, Dr Paul Clark, for this interview to find out what they think about ISO 13485 and how the usage of Stendard First™ has made this journey better.

Largest obstacles in ISO 13485

When you are a start-up with limited resources, the people available to put the processes in place are not always in their domain expertise. You can spend a lot of time and get nowhere not nearly fast enough!
— Dr Paul Clark, on their biggest ISO 13485 obstacle.

Being in the digital healthcare industry and constantly having to work with imaging centres and pharmaceutical companies, it is very clear to the management that compliance with ISO 13485 is the way to go in order to ensure a smooth path towards clinical adoption.

When asked about their biggest fears and obstacles with regards to the ISO 13485 journey, Paul shared, “The most daunting aspect, even having been through the process before, is getting all the procedures documented and linked across the organisation.”

“When you are a start-up with limited resources, the people available to put the processes in place are not always in their domain expertise. You can spend a lot of time and get nowhere not nearly fast enough!”, Paul amusingly added.

In fact, it is normal for Small & Medium Enterprises (SMEs), including start-ups, to look for alternate productivity tools, introduce software or try to implement a full electronic system to make up for the lack of resources and human capital. Most of the time, it barely solves the complete problem.

Conventional eQMS Methods

Electronic Quality Management System (eQMS) software, or an Enterprise Quality Management System (EQMS), helps companies systematise and comply with standards. They are very useful when it comes to managing your documents (for example, ISO 9001, ISO 14001 or ISO 13485), tracking document versions, electronic signatures and activities of employees within the software. While the pros are attractive, users often find it hard to ignore its cons too.

“We have explored a variety of software tools for QMS purposes and found that they are often too expensive for the features offered, and don’t offer a directed path for content creation. Some of them are counter-intuitive and difficult to interact with as well”, Paul shared.

Existence of Stendard First™

Stendard First™ is essentially designed to focus on the upstream portion of the entire ISO 13485 journey – the document creation process. Without taking the first steps to create a set of customised documents, the implementation of an eQMS software would be counter-productive and defeats the purpose of going electronic in the first place.

This explains why we named it Stendard First™, every journey ought to start from a first step forward

— Mr Jason Lim, CEO & co-founder of Stendard.

Paul also shared about his experience of using Stendard First™, “The entire Question & Answer approach is refreshing and easy to use, with a very clean interface.”

Document Review and Implementation

With Stendard First™ already supporting more than 20 companies within a month’s launch, it’s easy to wonder about what’s upcoming for Stendard.

To give all our blog followers a sneak peek, we are currently in late stage discussion to work with our top tier partners to provide Document Review supports.

At an affordable price, we will support early-stage companies to go through:

  1. Gap Analysis – To understand the current stage of the company and progress of commercial products
  2. Document Creation – Wholly supported by Stendard First™ and guided by an attached advisor
  3. Document Review – To complete the process by ensuring the document creation is fully customised and applicable to the company
  4. Training and Implementation (Optional) – To put all theoretical processes into practical application through several intensive sessions of training.

To find out more, fill out the enquiry form here stating your requirements.

Moving Forward

Every year, among the 38,000 ISO 13485:2016 certifications issued worldwide, there are many just like MagnePath Pty Ltd, who felt restricted and limited in resources. One word of advice, try out Stendard First™.

or click here to find out more about the features of 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!