Client Overview
A dental AI technology organisation operates in the highly regulated digital health and medical device sector, focusing on advanced 2D and 3D radiograph analysis. With AI-driven CBCT capabilities, the organisation supports clinicians in detecting dental pathologies that are often difficult to identify through visual review alone. Its platform enables faster diagnosis, digital second opinions, improved treatment planning, reduced radiation exposure, and stronger insurance claim support, helping dental professionals deliver more accurate, confident, and patient-centric care.
Background
The client aimed to enter a complex, multi-market regulatory landscape spanning the United States, Canada, Australia, and Europe. As a 20-member organization with medium operational complexity, it faced the challenge of strengthening its QMS, closing critical process gaps, and achieving audit readiness within a structured certification-focused compliance program.
Services in Scope
Gap analysis of the existing QMS.
Remediation support across all markets in scope.
QMS training for teams who are new to formal quality requirements.
Internal audit and mock audit execution.
Management review meeting support.
Problem statement
The client planned to enter multiple regulated markets, requiring enhancements to the QMS to manage complexity, close compliance gaps, and prepare for certification audits.
Key Challenges
Limited familiarity with ISO 13485, MDSAP, and QMS implementation expectations.
Market access depended on successful MDSAP certification.
SOPs required customization to match real-world processes and responsibilities.
Documentation needed remediation to close regulatory and audit-readiness gaps.
Training and mock audits were required to build audit confidence.
Solution overview
Freyr conducted a structured QMS gap assessment, remediated procedures and documents, and trained the client team to support ISO 13485, MDSAP, and software lifecycle compliance.
1
Reviewed current practices against applicable QMS, regulatory, and IEC 62304 requirements.
2
Customized SOPs to align with actual workflows, roles, and responsibilities.
3
Remediated documentation and implementation gaps to strengthen compliance readiness.
4
Delivered QMS training, mock audits, internal audits, and Management Review Meetings.
Approach / Methodology
1
Gap-led remediation approach combining document review, workflow alignment, team training, audit readiness, and management review support.
Impact
The client achieved MDSAP certification across three countries and ISO 13485 / EN ISO 13485 certification, enabling broader global market access.
Created and revised 40+ QMS documents to strengthen compliance, improve process alignment, and support audit readiness.
Established standardized, practice-aligned SOPs to build a robust QMS capable of supporting broader market access.
Enhanced team audit readiness through focused QMS training, internal audit support, management review support, and mock audits.
Achieved MDSAP certification across three MDSAP participating countries, along with ISO 13485 / EN ISO 13485 certification.
Received a 100% CSAT score, reflecting strong stakeholder satisfaction with project execution.
