Bridging the Gap Between R&D and Regulation in the Healthcare Industry

There have been massive advancements and innovations in the healthcare industry, specifically in the development of medical devices, digital health, and other pharma-related solutions that can impact our everyday lives. Behind the scenes, companies go through long and complex processes to ensure they release a product that is proven to work as intended while being in line with all relevant regulations. That means working with a development team to create the product, a regulation team or company to ensure it is up to code, and possibly even a third to carry out necessary procedures and documents for FDA/CE approval.

 This is where things get particularly complicated. The Development and Regulation teams need to communicate with each other in order to develop a product in parallel with preparing regulatory documentation efficiently. The only problem is that they don’t speak the same language. In most cases, R&D teams don’t understand regulatory issues and regulation teams don’t understand software development. Yet, they still need to deal with software regulation. The inherent misunderstanding between the two teams often leads to miscommunication, longer time-to-market, increased expenses, reduced productivity, lack of efficiency, and more.

How do companies bridge this gap while benefiting from experienced developers and regulations experts?

Bridging this gap is not simple. Ideally, companies should work with developers who know how to communicate with regulations companies and prepare relevant documentation. Finding such developers has proven to be nearly impossible since many are not experience in developing with a regulation mindset. Regulations companies, on the other hand, do not provide software development services and, in most cases, are not properly equipped to deal with complex medical software. As technology advances in the healthcare field, this is becoming a prevalent challenge.

A Bilingual Team that “Speaks” Development and Regulation

Recognizing the need for a bilingual team, one that “speaks” software regulation and development, MedDev Soft develops medical systems and software with an emphasis on providing all the necessary procedures and documents for regulatory boards. Their experienced team is made up of proven medical software engineers and software regulation experts who know how to communicate with each other efficiently. They also know how to properly communicate with relevant healthcare & pharmaceutical companies. Their track record of success has resulted in faster time to market, decreased costs, higher efficiency, and high-quality solutions.

MedDev Soft specializes in software development & regulation, working with startups and companies of all sizes in all product development stages. Based in Israel, MedDev Soft works with the most skilled engineers in the world, successfully delivering over 200 products to companies such as Boston Scientific, Philips, Medtronic, and many more.

How it Works

MedDev Soft’s team of experts will help you with software design, architecture, integration, and releases. These will each be tailored directly to your specific needs and requirements,  and compliant with regulation, maintaining clear lines of communication while supporting your internal teams along the way.

Their team treats themselves as your in-house team and working directly with your regulation team to ensure all software maintains the highest regulatory compliance. Unlike other medical system development companies, MedDev Soft knows regulation and software, two complex elements that rarely work together and often create friction. Working with anything less than the best leaves companies vulnerable to regulatory violations, or bulky and difficult-to-use systems.

MedDev Soft’s comprehensive knowledge of regulatory documentation significantly reduces the time it takes to deliver and begin implementing your new medical software solution. Thanks to its long-standing working relationships with its clients and extensive work with regulation companies, MedDev Soft is extremely familiar with the documentation and forms needed to satisfy regulatory demands in addition to delivering sound software solutions. From ideation to design, prototype to QA testing, MedDev Soft does the heavy lifting and deals with the burden of regulatory documentation.

For established companies, MedDev Soft steps in to help prepare any and all regulation documentation to ensure the software is up to the latest standards and ready to be launched. Startups often hire MedDev Soft’s team to develop the software and the regulatory documentation all in one. Wherever your company stands, MedDev Soft provides end-to-end services.

A Note from Dina Sifri, Founder & CEO of MedDev Soft

After working in the  healthcare industry for over 20 years, I’ve seen the communication and knowledge gaps between regulation and software teams. I’m all too familiar with the consequences companies suffered as a result of these gaps, hindering their ability to serve their patients and users properly. This is what drove me to create MedDev Soft over 10 years ago. Today, we are leading experts in the industry, have served over 200 clients of all sizes in the medical devices, digital health, and pharmaceutical market. We boast a vast knowledge of both software development and regulation in order to prepare all of the documentation needed for the regulatory file.

MedDev Soft grants you access to top technologies and developers while bridging the significant gap between development and regulation.

Interested in hearing more? Let’s connect and chat about how MedDev Soft can help you create innovative solutions while reducing time to market and costs.

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