Build team-centric Quality Management Systems (QMS) compliant with ISO 13485 and 2026 FDA QMSR.
Services
Custom QMS Architecture: Designing scalable, right-sized systems from the ground up for startups and global enterprises.
FDA QMSR Transition: Expert gap analysis and implementation to align legacy systems with 2026 regulatory mandates.
Digital Transformation: Selecting and optimizing eQMS platforms to automate document control, CAPAs, and training.
Risk-Centric Integration: Embedding advanced risk management (ISO 14971) into the product lifecycle to ensure continuous safety and audit readiness.
Build team-centric Quality Management Systems (QMS) compliant with ISO 13485 and 2026 FDA QMSR.
Services
Custom QMS Architecture: Designing scalable, right-sized systems from the ground up for startups and global enterprises.
FDA QMSR Transition: Expert gap analysis and implementation to align legacy systems with 2026 regulatory mandates.
Digital Transformation: Selecting and optimizing eQMS platforms to automate document control, CAPAs, and training.
Risk-Centric Integration: Embedding advanced risk management (ISO 14971) into the product lifecycle to ensure continuous safety and audit readiness.