Regulatory Affairs
Making Regulatory Affairs Comprehensive - From Idea to Market
Navigating the medical device industry's evolving regulatory landscape can be challenging. At GBA Group, our experts are adept in global regulations, offering specialized support for businesses of all sizes. We assist you throughout the product lifecycle, whether you need specific task help, a second opinion, or daily business support. Our flexible approach allows us to work on-site or remotely to meet your regulatory needs efficiently and effectively.
Regulatory Strategy & Consulting
Our team specializes in product qualification, risk classification, regulatory strategy, and technical documentation. We provide expert guidance on global regulations, supporting you with product purposes, similar devices, standards, and interpretations of relevant regulations and documents.
Product Development & Lifecycle Management
We assist your product from concept to market and beyond, focusing on post-market activities. Our expertise in medical device and IVD development ensures reliable execution and compliance with safety standards, supported by extensive risk documentation.
Design, Development & Manufacturing Procedures
Our meticulous processes for medical device design, development, and production ensure efficiency and compliance. Our guiding documents offer essential knowledge and tools for our clients.
Global Market Entry & Product Registration
We help you bring safe and effective products to market by achieving CE marking for EU access, processing FDA submissions, and supporting global registration of your medical device or IVD product.
IVDR Compliance Made Simple
We simplify IVDR compliance, guiding you through implementation to ensure seamless and successful compliance. Rely on our expertise to navigate the regulatory landscape. Read more
Risk Management Introduction Package
ISO 14971:2019/A11:2021 harmonization with EU Medical Device Regulation (MDR) 2017/745 and IVDR 2017/746 is crucial for compliance and patient safety. Our experts facilitate this process for your organization.
Rely on our experts
“Navigating regulatory requirements is essential and acts as a compass to ensure safe and effective medical devices reach those in need”
Helena Dahlin, Director of Regulatory Affairs.
GBA Key2Compliance
To learn more about our comprehensive services in Regulatory Affairs and discover how we can support your business, visit the GBA Key2Compliance website. Our experts are ready to assist you with tailored solutions to meet your regulatory needs.