Your partner in setting up and keeping your QMS up to date

Effective QMS support will ensure the delivery of safe, high-quality products for healthcare professionals and patients. From the beginning, we will help you establish a robust QMS that aligns with international standards and regulatory requirements. Our team of experts will support your organization in developing, customizing, and implementing essential procedures, templates, and work instructions, ensuring the efficiency of all processes. We will collaborate and guide you in identifying areas for enhancement through ongoing internal and second-party audits (ISO 19011) and providing an efficient guide during QMS third–party audits. Ultimately, we can drive you to select and implement a QMS cloud solution, ensuring the continuous effectiveness of your quality management system.

Strong experience in handling QMS and process improvement

– We offer a dedicated team of experts including qualified auditors, to lead you through the essential steps of implementing and enhancing your QMS in alignment with various regulatory frameworks. 

– We aim to support every company, from innovative start-ups to well-structured enterprises. 

– We empower companies to evolve continuously, establishing and meeting regulatory requirements by ensuring product quality, safety, and compliance. 

KEY FIGURES

5+

QMS implementations from scratch

2+

Improvement of structured QMS supporting the improvement of structured QMS

PLG support was essential to reach ISO 13485 certification.

Innovative Medtech customer

Innovative Medtech customer