QUALITY ASSURANCE
Ensuring Quality and Compliance for Medical Devices
At GBA Key2Compliance, we understand the critical role medical devices play in healthcare. We are dedicated to supporting manufacturers in delivering safe, effective, and compliant products to the market. Our approach is tailored to each client’s unique needs, ensuring a personalized and efficient service.
Contact us to learn more about our services and how we can assist you in your journey towards quality and compliance excellence or just good enough.
We know the requirements - and ensure you meet them
Learn more about our services and how we can help you
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
Simplifying your journey to MDR Compliance
Navigate the complexities of the Medical Device Regulation (MDR). With our guidance, we streamline MDR compliance with thorough gap assessments, technical documentation review, and clinical evaluation support. We help you develop a robust post-market surveillance strategy and optimize your QMS to align with MDR requirements. Our customized training programs empower your team with the knowledge and skills for MDR 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!
Fulfill USA market regulations with QSR compliance
Simplify your entry into the USA market with our expert guidance. We will assist you in navigating the intricate FDA requirements, ensuring a seamless and successful compliance experience. Count on our support and expertise, so you don’t have to navigate the regulatory landscape alone.
MDSAP Compliance made simple
Get your Quality Management System (QMS) ready for a MDSAP (Medical Device Single Audit Program) audit with our assistance. We will conduct a thorough GAP analysis, make necessary updates, and conduct a Mock audit.
Rely on us - meet our experts
“With an experienced team and extensive knowledge, GBA Key2Compliance provides comprehensive quality assurance services for medical device manufacturers. We support roles like Quality Manager, QA/RA, and PRRC, conduct GAP analyses, audits, and assist during Notified Body audits, ensuring robust quality management systems and audit readiness.”
Helena Dahlin, Director of Quality Assurance & Regulatory Affairs
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