Our Solutions

Navigate complex EU regulations with confidence.

Expanding into Europe can be challenging. QbD Group helps you interpret requirements, streamline submissions, and achieve full compliance for a smooth and successful market entry.

We help biotech innovators translate discoveries into viable products. Our experts guide you in regulatory strategy, quality systems, and product development to build a solid foundation for growth.

Future-proof your manufacturing with data-driven compliance.

QbD Group supports AI-driven, Annex 1-compliant manufacturing. We ensure data integrity, digital validation, and secure site transfers for efficient and compliant operations.

Navigate complex EU medical device regulations with confidence.

QbD Group guides you through MDR and IVDR requirements, from classification and CE marking to Notified Body interactions, ensuring a smooth and compliant market entry.

Accelerate your innovation journey.

We help MedTech startups turn ideas into market-ready devices through expert guidance in regulatory strategy, quality management, and product development for sustainable growth.

Ensure your software meets the highest quality and regulatory standards.

QbD Group combines technical and regulatory expertise to help you develop safe, effective, and compliant medical software that meets the highest quality standards.