Hi there, firstly could you tell us a little about SoftComply and the motivation behind your company?
SoftComply was founded with the idea of helping small and agile medical device companies get their innovative products to market faster so that they would reach and help – us – quicker.
Medical devices are regulated across the world in order to ensure their safety and efficiency; before they are launched in any market they are subject to country-specific requirements: in the EU any new medical device must achieve the CE mark; in the US, the FDA approval is required for most medical devices. Becoming regulatory compliant is both resource and time-consuming - something smaller companies rarely have in abundance.
Who are the key figures involved in SoftComply, and what are their backgrounds?
SoftComply has 3 founders:
Matteo Gubellini, with his international medical device regulatory experience, is our expert in regulation and design controls; Margus Nael, with his extensive software industry experience, is our expert in software development and the different software platforms; and Marion Lepmets, with her extensive academic background and knowledge of international medical device standards, is the CEO - running the business on a day to day basis.
SoftComply are specialists in software development and regulatory affairs in the medical devices industry. How does this mix of software and legislative insight combine, and what does this combination offer to potential clients?
A lot of companies struggle to understand and implement the requirements of international standards or the guidance of various regulatory agencies. We aim to make this sometimes daunting process much easier and more affordable by creating comprehensive plugins that are part of a medical device company’s everyday working tools.
We decided to initially develop these plugins on the Atlassian platform because it is well established and very popular in the agile software development domain. Atlassian is slowly but steadily also winning ground in the regulated domains such as medical devices.
There are two basic, minimum regulatory requirements a medical device company needs to meet in order to market their products – a Quality Management System (QMS) compliant to the regional regulations where the product is going to be released, and a compliant Risk Management process.
We have created user friendly Atlassian add-ons for both of these – the SoftComply eQMS to fast track the development and implementation of ISO 13485 and 21 CFR 820 compliant Quality Management System as an add-on for Atlassian Confluence; and the SoftComply Risk Manager for ISO 14971 compliant risk management process as an add-on for Atlassian JIRA.
Medical technology is a particularly sensitive industry, and with it comes a wide range of different compliance obligations, both CE within Europe, and the FDA across the Atlantic in the USA. How does SoftComply’s offering and expertise help to expedite the process of compliance?
Our main objective is to provide regulatory compliance tools that are easy to use, affordable and speed up this usually time-consuming process.
We have built regulatory compliance into the software development lifecycle - our add-ons are completely integrated within Atlassian tools.
Our add-ons have a low entry price following Atlassian’s own pricing model where license fees are proportional to the size of the company, i.e. extremely low starting price for SMEs. On top of that, it is a pay-as-you-go SaaS licensing model on a monthly basis.
SoftComply Risk Manager will allow you to automate your risk management process, thereby accelerating the entire compliance process. SoftComply eQMS is essentially a complete Quality Management System where you only need to add your company and device specific details.
Using SoftComply products can cut your medical device company’s regulatory compliance costs by 10 times.
What would you say is the central value of a company working in digital health in using a third party such as SoftComply in navigating laws and regulations regarding health care products?
SoftComply allows a medical device company to focus on their own competitive advantage of creative healthcare and medical device products rather than trying to navigate their way through complex standards and regulations by themselves. Leave the boring stuff to people who love that kind of thing and instead focus completely on your business growth!
SoftComply is based both in Estonia and Ireland, two countries known within Europe for their high-tech economies and embrace of digital innovation. Could you offer any insights into the digital health industries within both of these EU countries?
Estonia is known for its highly advanced technological innovations being home to companies like Skype, Transferwise, Starship Technologies – to mention a few. Estonia is also a country with one of the most digitally advanced governments (e-ID, e-residency, e-government, online voting, etc) and is well ahead of many other EU countries with its connected health solutions (e.g. e-pharmacies).
Ireland is recognized as the country where most medical device multinationals have established their European headquarters. In addition, Dublin is one of the most buzzing European cities with software companies like Google, Paypal, Amazon, eBay – to name a few – having large offices here. Medical device and healthcare industry is one of the strategic areas of interest for the Irish government. Being the country with the youngest population in the EU, it is almost symbolic that it aims to create a better medical device and healthcare system for the aging population of Europe and the rest of the world.
As the UK heads towards ‘Brexit’, is there any message SoftComply has for British digital health companies? How might SoftComply be able to help with compliance as the UK’s relationship with the EU changes in the coming years?
Although many countries have specific regulatory requirements when it comes to medical devices, most of these requirements are harmonized across the world. Safety and efficiency have to be ensured always, regardless of the country where your products are marketed.
We do not believe that the UK would want to change their medical device regulations to differ from the Medical Device Regulation (MDR) of the EU and not allow new medical innovations reach their citizens at the same time as the rest of the EU.
Connected Health Profile: http://connectedhealth.ee/members/softcomply/
Contact us at: E-mail: email@example.com
Phone: 0845 643 5375
Estonian Digital Health Series: An interview with SoftComply first published on Company Connecting February 2017