Quality Assurance
Ensuring Quality and Compliance for Medical Devices
At GBA Group, we recognize the crucial role that medical devices play in healthcare. Our mission is to support manufacturers in delivering safe, effective, and compliant products to the market. We provide personalized and efficient services tailored to each client’s unique needs.
Our Services
- Regulatory Compliance: We navigate complex regulations such as MDR, IVDR, and QSR to ensure all necessary standards are met.
- Validation and Verification: We guide the validation and verification processes, including design verification, software validation, and process validation.
- Quality Management Systems (QMS): We help implement and optimize QMS processes like document control, risk management, CAPA, and change management. Read more
- Person Responsible for Regulatory Compliance (PRRC): We provide PRRC services for companies with fewer than 50 employees, meeting all training and experience requirements.
- Quality Manager or QA: Our consultants can serve as Quality Managers or QA, ensuring regulatory compliance and the execution of quality activities.
- Auditing and Inspection Readiness: We prepare companies for regulatory audits and inspections through internal audits, documentation, and adherence to requirements.
Simplifying Compliance
- IVDR Compliance: We guide you through IVDR implementation for seamless compliance. Read more
- MDR Compliance: We streamline MDR compliance with gap assessments, documentation review, and clinical evaluation support. Read more
- QSR Compliance: We assist with FDA requirements for a smooth entry into the USA market.
- MDSAP Compliance: We prepare your QMS for MDSAP audits with thorough GAP analysis and mock audits. Read more
Why Choose GBA Group?
“With an experienced team and extensive knowledge, we provide 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.”
Åsa Möllby, Director of Quality Assurance
GBA Key2Compliance
To find out more about our comprehensive services and how we can assist you in ensuring the quality and compliance of your medical devices, visit GBA Key2Compliance website. Discover the full range of support we offer beyond what's detailed here and see how we can tailor our solutions to meet your specific needs.