Medical Software Regulatory Consultations
Are you navigating the complex landscape of medical software development?
Whether you're:
Starting a Medical App Development: Seeking clarity on the Medical Device Regulation (MDR) and its impact on your software
Implementing ISO 13485 Quality Management System as a tech company: exploring the ways of implementing an ISO 13485 Quality Management System (QMS) and looking for guidance
Planning to get CE-marked: Preparing for the pivotal step of obtaining CE marking and achieving MDR certification to ensure your product meets European regulatory standards
We're here to simplify your journey towards compliance and excellence in the medical software sector.
Why we want to help you
We know how hard it can be to understand all regulations and standards and to apply them within your medical app, software or system. Some documents take hundreds of pages in complicated legal jargon.
We're here to help you understand where to start and what to do. We want to make MedTech more accessible by helping businesses with our expertise in compliance for medical software projects.
If that resonates with you, we provide a complimentary one-hour consultation for free to offer high-level guidance at the beginning of your compliance journey.
How can we help
Regulatory Consultations
Compliance Audit
ISO 13485 Quality Management System Implementation
Medical Software Development
Free first hour of regulatory consultations
If you’re not too sure about what you need, we’ve got you covered.
We provide a complimentary one-hour consultation to offer high-level guidance on the beginning of your compliance journey.
Our assistance is available to businesses of all sizes, and there are no obligations – it's all about supporting you!
Who will you meet with
Małgorzata Gonsior-Kustosz, PhD
Martyna Piecko
Wanda Sordoń, PhD
Łukasz Bandała
We are ISO 13485 certified = less documentation for you
We proudly hold the ISO 13485 certification, showing our commitment to a high-quality management system for design and development of medical software.
For you, it means that you don’t have to do extra paperwork to prove we are a high-quality supplier. Instead of additional excess forms, you just check a box, and it’s done!
Some regulatory topics you can read about on our blog
Want to read more on medical software compliance?
Maybe one of our blogposts will help you?
Get in touch with us
Whether you’re interested in a free hour of consultation with our experts, or you’d prefer other guidance on regulatory compliance - we’re always here for you.
Let us know what you need and we’ll get back with a personalised solution for your request.