Guiding Medical Device Startups on the Road to CE-mark
We believe that regulatory compliance should be a catalyst for innovation, not a roadblock!
At GBA Key2Compliance we recognize that startups in the MedTech industry face a distinctive set of challenges that make their journey to bring innovative products to market a bit rocky. We understand the pressures of innovation, limited resources, and navigating complex regulations.
Therefore, we offer tailored consultancy services to resolve the hurdles that startups encounter. From idea to market entry, we’re here to guide you through every crucial step of the compliance process. Let us help you turn your innovative ideas into successful, compliant products!
Need help in determining the classification of your medical device?
Understanding your product’s classification is essential for ensuring regulatory compliance and successfully bringing your innovation to market.
GBA Key2Compliance has developed an AI-powered service that provides your product’s classification within seconds. It’s user-friendly and completely free!
Here’s how it works: Just answer a few questions about your medical device, and let our AI provide you with the classification of your innovation.
Discover Our Informative Tutorials!
If you’re a startup seeking guidance in this complex field, our tutorials offer step-by-step insights. Our tutorials provide understanding about medical device regulations and the CE marking process.
Our ‘Medical Devices from Idea to Market’ tutorials consist of seven informative lessons. These tutorials simplify complex regulations, assist in identifying applicable ones, and cover critical topics such as Quality Management Systems and risk management. Whether you’re in the development stage or aiming for market access, our tutorials provide the knowledge you need for a successful product launch.
Comprehensive Regulatory Solutions and Expertise for Startups
GBA Key2Compliance specializes in creating tailored regulatory strategies that align with your startup’s goals, ensuring a clear path to compliance with FDA and CE marking regulations.
Our core areas of expertise include:
We help startups maximize the use of their limited resources in an efficient manner, ensuring that budgets and personnel are allocated effectively for compliance efforts.
Regulatory requirements are constantly evolving. Our experts help you in every step of the way and adapt to your compliance strategies to stay current with changing regulations, preventing disruptions to product development.
We are experienced in establishing and maintaining QMS that meet industry standards. We can, together with you, build your QMS from scratch. We also help you with internal audits, GAP analysis, internal audits, non-conformities, increase of effectiveness or give you a QA/RA refreshment.
Our consultants offer expertise in managing clinical trials and testing processes efficiently. We help startups design cost-effective trials and navigate the complexities of testing requirements to meet regulatory standards.
We assist startups in establishing mechanisms for ongoing surveillance and reporting, ensuring compliance with regulatory requirements, and maintaining product safety.
Get In Touch With Our Experts
We have dedicated experts of every service of our business. Feel free to leave your contact details and we will find the right solution just for you.
