Marion Lepmets from SoftComply: MedTech, regulatory compliance, and the Peruvian Rainforest
Marion Lepmets is the co-founder and CEO of SoftComply,
SoftComply offers two add-ons for MedTech industry - one is the content based addon for Confluence that kickstarts the development of a compliant Quality Management System, the other is an add-on for Jira to automate compliant risk management process and generate risk reports for regulatory audits. In other words, SoftComply offers Atlassian add-ons for regulatory compliance to get your products to market faster. Read on to discover Marion’s take on helping medical device companies tackle compliance challenges as well as some interesting and intense hobbies held by members of the SoftComply team!
SoftComply was founded 2 years ago by 3 people––Matteo Gubellini, our Regulatory Affairs Manager with a lot of experience in regulatory compliance in MedTech and pharma industries; Margus Nael, our CTO and in-house Atlassian guru (Certified Atlassian Expert) and myself. We are still a young startup when it comes to our Atlassian add-ons but we have serious domain knowledge from medical device industry.
Medical device companies have to adhere to regulations in order to get their products on the market. Both large hospital devices as well as iPad/iPhone apps that are intended for medical use, have to comply with regulations. This takes a lot of time, money and expertise. Things MedTech startups might not always have too much of.
After several years in medical device research and seeing many MedTech companies struggling with regulatory compliance in the agile/rapid software development world, we decided to create tools to help them. There are regulatory compliance solutions out there today but they are standalone tools that are primarily built from the Regulatory Affairs perspective, i.e. they are not the most natural fit for software developers. We wanted to take a different approach, that of software teams and of startups. Atlassian is the number 1 platform for agile development today, we wanted to create regulatory compliance tools on it that would allow us to tie regulatory compliance into the software development environment rather than the other way around. Our aim is to reduce the time and cost it takes to put complex medical innovations on the market so that we could all use them quicker. Using SoftComply eQMS will considerably reduce the time to implement a Quality System in an organization.
The minimum requirements for any MedTech company are to have a compliant Quality Management System and a compliant Risk Management process. In the latter, the software needs to be analyzed in terms of the potential harm that its failure could result in. Risks have to be linked to requirements and test cases for full traceability that auditors are checking before allowing the product to be placed on the market. SoftComply Risk Manager is an add-on for Jira automating risk management for MedTech but also other regulated industries.
We are exhibiting our add-ons at some of the more popular European medical device conferences-exhibitions (Medtec Europe in Stuttgart, MEDICA in Düsseldorf to mention a few)––hoping to meet all LifeScience companies using Atlassian there! ;)
Above you can find a photo of the founders––Margus is on my right, Matteo on my left with the North Face jacket.
Oh, for fun––Margus is huge into triathlon and takes part in some seriously demanding IronMan competitions around the world. Matteo is a volleyball enthusiast––he is a volleyball coach and a referee when he is not playing himself. I love sailing and hiking, i.e. traveling the world, in general, every chance I get (am writing this in Chivay near the Colca Canyon in Peru before heading to Manu National Reserve to explore the rainforest for a week).
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Thank you, Marion! If you have questions about SoftComply, please leave them in the comments section below!
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