MedDeV

About

Together we turn your groundbreaking concepts

into state-of-the-art reality!

We help medical & digital health companies bring their products to market and accompany the process throughout the life cycle of the product, Whether it’s a medical device or a software. The services we provide allow
our clients to get to market faster, streamline the regulatory process, minimize risk and cut costs.

Our team of experts specializes in software development, regulatory, quality processes, Verification & Validation, cyber security, risk management, ISO certification and basically everything that needs to be addressed during the development and approval process of the product, before and post marketing.

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. We incorporate the most updated FDA, MDR and more guidelines and regulations, best practices and latest tools in the industry, based on your company’s specific needs.

ABOUT


We are committed to helping our clients resolve medical device design and development challenges. Our staff consists of teams of medical device developer experts, project managers, regulation and SQA senior consultants, cyber and risk pro’s, working exclusively on projects in the medical device software development industry.

Helping You Meet Regulatory Goals

MedDev Soft is ISO13485 registered and IEC 62304 compliant, so the work product we produce for our clients is consistent with the highest industry standards.
Our clients often leverage our ISO certified QMS, ALM, and experience. So you can rely on our quality system during the process of achieving your own. Or, if you prefer, we can work with your team to develop your own quality system in a cost-effective manner.

Helping You Meet Regulatory Goals