ABOUT US

Turning groundbreaking concepts into state-of-the-art reality, MedDev Soft team helps companies of all sizes bring their products to market through software development, software regulatory file preparation, Verification &Validation, training, and high-level consulting.

Helping companies realize the reality of their FDA/CE approved solution is what we’ve been doing since 2010. Complex imaging, precision scanning, and Proof of Concept development has enabled our clients to recognize greater success internationally, thanks to our team’s development skills and full lifecycle management.

Delivering solutions beyond development, our SQA team tests, plans, and trains teams in the proper FDA & CE practices. These focused partnerships increase efficiency while reducing time to market for Medical Devices, Digital Health, and Pharmaceutical companies.

With our Partnership Approach, we work together to properly understand all your project’s parameters. From functionality to regulation, we handle all project aspects so you can prepare for your product’s launch or ongoing field use. Aware that each project is unique we’ll dive deep to deliver accurate needs, budget, and timing expectations.

Whether it’s a single project or ongoing maintenance, we’re with you from kick off to live implementation.

MedDev Soft specializes in software design, development, testing and regulation for the medical device and pharmaceutical industries. Through vast experience working with startups, enterprises, and various medical device companies, we’ve been delivering proven results since 2010.

Partnering with healthcare and pharmaceutical companies who need to shorten their delivery time to market for medical device software, digital health technologies, and mobile medical device applications by successfully navigating the FDA and CE approval process.

We constantly invest in the most state-of-the-art technology and regulatory updates, shortening turnaround times and allowing projects to progress from the first day. Working with the most advanced technology in the medical device industry allows our engineers to work efficiently saving our clients time and money.

Our team of skilled engineers are highly educated, highly trained, and completely focused on the needs of our clients. We design our clients’ products with a focus on the user needs and requirements, while making smart design choices based on our extensive and diverse product development experience.

Our goal is to make sure you’ve developed the highest-level product and get the FDA approval and CE Marking you need to bring your device to market.

MedDev Soft has developed more than 200 medical device products for over 150 companies, ranging from Class I through Class II diagnostic and therapeutic systems and up to Class III implantable devices. This has been achieved using embedded system, PC based devices, smartphones/tablets, and web/Cloud services.

We are proud to have worked with such prestigious organizations such as About, St. Jude Medical, Medtronic, Boston Scientific, Philips, GE, Johnson & Johnson, and many more. We have also partnered with a number of early-stage companies to help them bring revolutionary products to market.

In each case, we produce the right product in the right timeframe with the right budget.

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