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
Regulatory Consultations
Get high-value compliance knowledge from our industry experts. Some topics you might be interested in:
- Medical Device Regulation (MDR) Guidance
- U.S. Food and Drug Administration (FDA) Regulations
- ISO/IEC Standards: In-depth discussions on IEC 62304, IEC 82304, IEC 62366, ISO 13485, ISO 14971 or other relevant standards.
Compliance Audit
Interactive sessions focused on applying knowledge to your exact case. We’re going to work out the crucial information about your project to make sure which regulations and standards apply to you and what conformity assessment procedures should be chosen to confirm safety and effectiveness of your product.
- Defining the Intended Use of Your Product
- Product Classification
- Developing a Regulatory Strategy and Market Entry Plan
- Compliance Audit Report: Assessment of current processes, systems, and compliance readiness with identification of improvement areas.
ISO 13485 Quality Management System Implementation
If you're looking to obtain a CE mark, it's essential to note that you’re obliged to have an implemented Quality Management System. We can assist companies like yours in implementing a QMS compliant with ISO 13485, while seamlessly integrating aspects of the MDR into your day-to-day operations.
- Establishing the company's strategy, quality policy and quality goals
- Design of a quality management system and process map
- System documentation: procedures, instructions and related forms for the effective use of the implemented system in practice
Finally, we will help you choose a notified body, we will be with you during the certification audit and provide support until you obtain a certificate for your company's QMS.
Medical Software Development
We partner with clients who are developing their solutions providing expert guidance in designing, creating, and maintaining medical software, complete with comprehensive MDR/FDA documentation support. This includes preparation for and assistance throughout the CE certification or FDA approval process.
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
Head of Regulatory Affairs and an expert in innovative medical technologies with a background in medical physics, and as a manager of over 30 R&D projects in MedTech. In the medical devices industry since 2007. Her PhD focused on Materials Engineering.
Martyna Piecko
Regulatory Affairs Specialist, MSc in Biomedical Engineering and active Physiotherapist with a scientific background in biomechatronics and the human musculoskeletal system. Expert in registration processes for MDR, FDA and foreign countries. Specialises in integrating regulatory compliance and medical device safety.
Wanda Sordoń, PhD
Regulatory Affairs Specialist, PhD in Analytical Chemistry and Electrotechnical Techniques and MSc in Biomedical Engineering with broad experience in medical device compliance, especially technical documentation in accordance with MDR 2017/745.
Łukasz Bandała
CTO & co-CEO of Revolve Healthcare. MSc in Computer Science in Control and Management and BSc in Biomedical Engineering. Expert in technical supervision of quality management processes in medical software development projects.
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.