REGULATORY AFFAIRS
Making Regulatory Affairs Comprehensive - From Idea to Market
Navigating the medical device industry’s ever-changing regulatory landscape can be complex. At GBA Key2Compliance, our regulatory specialists are experts in global requirements for medical devices and in vitro diagnostics (IVDs), supporting businesses of all sizes – from startups to established corporations.
We ensure your products meet all legal, safety, and performance standards throughout the entire product lifecycle. Whether you need help with specific regulatory activities, a second opinion, or ongoing support, we offer flexible solutions tailored to your needs – on-site or remotely.
With deep knowledge of EU MDR/IVDR, FDA regulations, and ISO standards, we help you bring safe, effective, and compliant products to market – efficiently and confidently.
We know the requirements - and support your business in meeting them
Learn more about our services and how we can help you ensure your Regulatory Compliance
Want to learn more about the road to CE-mark for your medical device?
The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.
In this guide, you will find:
- Detailed Overview: A comprehensive look at the CE marking process from initial concept to market entry.
- Regulatory Framework: Insights into the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- Quality Management Essentials: Steps to establish and maintain a Quality Management System (QMS) that complies with EU standards.
- Practical Tips: Expert advice on navigating the certification efficiently to save time and avoid common pitfalls.
Download our guide and start your road to CE mark!
Regulatory Compliance - Reduce risk and open for new markets
We offer you our global regulatory expertise and are always available for guidance, second opinions, and specialized consulting services.
IVDR Compliance made simple
Simplify your path to In Vitro Diagnostic Regulation (IVDR) compliance. Let us guide you through the complexities of IVDR implementation, ensuring a seamless and successful compliance experience. Don’t navigate the regulatory landscape alone – Rely on us
Rely on our experts
“Navigating the complexity of regulatory requirements is not only necessary, but also a compass that will guide you on the journey to ensure that safe and effective medical devices reach those who are dependent on them, for their well-being and even their survival.”
Helena Dahlin, Director of Quality Assurance & Regulatory Affairs
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Classify your medical device with our AI powered service
Navigating the intricate landscape of regulatory affairs has never been this straightforward.
GBA Key2Compliance presents an advanced AI-classifier, engineered to simplify the classification of your medical device. Our tool is tailored for professionals in the field seeking to transform their idea into market.
Click below to access our free AI-classifier!
Discover your product’s classification within seconds to stay up-to-date with regulatory changes
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