ISO 13485
Quality management system aligned with medical device manufacturing requirements.
Compliance
Certifications
Compliance documentation supporting hospital onboarding, distributor agreements, and export programs.
CE Mark
Conformity pathways supporting distribution into applicable European markets.
FDA Registered Facility
Facility registration documentation available for US-bound procurement programs.
Material Compliance
Surgical stainless grades selected for autoclave durability and clinical performance.
Need certificates for a tender or vendor onboarding pack? Contact sales with your destination market and we will share the applicable documentation set.