From ISO 14971 risk management to global market registration, we provide end-to-end consulting that gets your device approved — fast, compliant, and audit-ready.
Our specialty is building and remediating Quality Management Systems and Risk Management Files that regulators actually accept.
Complete Risk Management Files: plans, hazard analyses (HACCP/HAZOP), DFMEA/PFMEA, benefit-risk analysis, and post-market surveillance integration. Our frameworks support submissions to FDA, EU MDR, Health Canada, and SFDA.
From gap assessments to complete QMS build-outs: SOP development, internal audits, CAPA management, supplier quality, and eQMS configuration. We maintain a single, global QMS compliant with FDA QSR, EU MDR, Health Canada, and SFDA.
We support medical device manufacturers across all major regulatory jurisdictions, ensuring your documentation meets every authority's expectations.
Strategic predicate selection, testing plans, eSTAR preparation, and pre-submission meeting support for successful FDA clearance.
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MDR transition, GSPR compliance, Clinical Evaluation Reports, Post-Market Surveillance plans, and Notified Body audit preparation.
Learn moreGHAD e-submission, Technical File Assessment, device classification, bilingual labeling, and MDMA renewal strategy for Saudi market access.
Learn moreWhether you've received a 483, need to update legacy documentation, or want proactive quality support, we have you covered.
Traceability rebuilding, technical documentation updates, recall prevention, and audit/483 response for legacy devices.
Learn moreDesign history files, device master records, V&V protocols, and design review facilitation aligned with FDA and ISO requirements.
Learn morePMS plans, periodic safety update reports (PSURs), complaint handling, vigilance reporting, and trend analysis across all jurisdictions.
Learn moreBook a free consultation and we'll assess your current state, identify gaps, and recommend a tailored plan — no obligation.
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