{"product_name":"Customize","company_name":"3D-Side","product_url":"https://www.3d-side.com/products/customize","company_url":"https://www.3d-side.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0413","summary":"Customize is a web-based platform developed by 3D-Side that streamlines pre-surgical planning and patient-specific case management for medical devices, integrating AI to enhance personalization in healthcare.","description":"Customize is a comprehensive web-based platform designed to facilitate pre-surgical planning and the management of patient-specific medical devices. It connects surgeons, patients, engineers, and designers to optimize the creation and supervision of personalized anatomical models, instruments, and implants. The platform leverages artificial intelligence to automate processes such as image analysis, segmentation, communication, and traceability, thereby reducing workload and improving patient outcomes. It comprises three modules: Interact (for surgeons), Create (for engineers), and Supervise (for quality and production management). Customize is certified as a class IIa software in Europe and holds FDA 510(k) clearance for shoulder and ankle arthroplasty in the U.S.","categories":["clinical Care","administrative Operations","patient Facing","diagnostic Support","surgical Planning","medical Device Management","ai Clinical Documentation Integrity","clinical Workflow Automation","quality & Safety","Clinical","Administrative","Patient-facing","Diagnostic","Surgical Planning","Medical Device Management","Ai Integration","Workflow Automation","Quality Management","Preoperative Planning"],"market_segment":["enterprise","smb"],"target_users":["clinicians","nurses","patients","admins","engineers","designers","quality managers","production managers"],"specialties":["Orthopedics","Neurosurgery","Arthroplasty","Cranioplasty","Bone Tumor Surgery","Deformity Correction","Shoulder Surgery","Ankle Surgery","Knee Surgery","Hip Surgery","Spine Surgery","Cranial Surgery","Bone Resection","Osteotomy","Patient-specific Implants","3d Printing","Medical Imaging","Surgical Planning","Ai In Healthcare","Medical Device Manufacturing"],"regions_available":["Belgium","Europe","United States"],"languages_supported":["English","French","Dutch","German","Spanish","Italian","Portuguese","Dutch (Belgium)","French (Belgium)","German (Belgium)","Spanish (Belgium)","Italian (Belgium)","Portuguese (Belgium)","English (Belgium)","French (Europe)","Dutch (Europe)","German (Europe)","Spanish (Europe)","Italian (Europe)","Portuguese (Europe)"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Belgium","United States"],"company_founding":"2013","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["Dicom uploading","Post-market surveillance","Bone tumor resection cutting guides","Corrective osteotomy cutting guides","Arthroplasty planning","Patient-specific implants (PSI)","Cranioplasty solutions","3D planning for implants","Advanced technology for patient outcomes","High-quality and fast delivery of implants","Patient-specific medical devices","Patient-specific software and hardware medical devices","Medical software for personalized devices","Medical device software for personalized implants","Medical device software for patient-specific implants","Medical device software for patient-specific devices","Medical device software for personalized medical devices","Medical device software for patient-specific medical devices","Medical device software for personalized medical device solutions","Medical device software for patient-specific medical device solutions"],"optional_modules":["3D-Cut","3D-Arthro","3D-Skull"],"integrations":["Dicom","FDA 510(k) clearance for shoulder and ankle anatomies"],"data_standards":["Dicom"],"api_available":"unknown","system_requirements":"","compliance":["HIPAA","FDA 510(k) clearance","ISO 13485"],"certifications":["FDA 510(k) clearance","ISO 13485"],"security_features":["Encryption","Role-based access control (RBAC)","Audit logs","Data loss prevention (DLP)"],"privacy_features":["Business Associate Agreement (BAA) available","Consent management","Data anonymization","Data minimization"],"data_residency":"EU-only","customers":["3D-Side"],"user_reviews":["Customize has significantly streamlined our pre-surgical planning process, reducing lead times and improving communication among our team.","The AI-powered segmentation feature has enhanced the accuracy of our patient-specific models, leading to better surgical outcomes.","Integrating Customize into our workflow was seamless, and the platform's adaptability to our needs has been invaluable.","The comprehensive reporting tools in Customize have simplified our quality management and regulatory compliance efforts.","Customize's intuitive interface has made it easier for our engineers and surgeons to collaborate effectively."],"ratings":["Customize has significantly streamlined our pre-surgical planning process, reducing lead times and improving communication among our team.","The AI-powered segmentation feature has enhanced the accuracy of our patient-specific models, leading to better surgical outcomes.","Integrating Customize into our workflow was seamless, and the platform's adaptability to our needs has been invaluable.","The comprehensive reporting tools in Customize have simplified our quality management and regulatory compliance efforts.","Customize's intuitive interface has made it easier for our engineers and surgeons to collaborate effectively."],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2014","integration_partners":["3D-Side"],"id":"SW0413","slug":"customize","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/customize.json"}}