Regulatory Documents
Medical devices are regulated by national authorities and international rules. All Orfit products comply with these rules and regulations and are, as such, freely available all over the world.
FDA stands for the U.S. Food and Drug Administration, an agency of the United States Department of Health and Human services. The FDA legislation protects the public health through the regulation and supervision of food and medical products. Our products are in compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act) Code of Federal Regulations Title 21 part 808/812/820.
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REACH is the European Community Regulation for chemicals and their safe use. REACH is the abbreviation for Registration, Evaluation, Authorization and restriction of Chemical substances. The purpose is to protect human health and the environment by a better and earlier identification of the intrinsic properties of chemical substances. According to this law, substances of very high concern may no longer be used in products.
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Products that are brought onto the European market must meet the essential requirements of the European product CE marking certification regulation. With this mark, we declare that all products made by Orfit Industries comply with the essential requirements of the European health, safety and environmental protection legislation (Regulation (EU) 2017/745).
Search and download the Declaration of Conformity here.
Search and download the Declaration of Conformity here.
ISO is the International Organization for Standardization. ISO facilitates and supports international trade by developing standards. These standards are recognized and respected worldwide. Orfit Industries is certified for the Quality Management System ISO 13485 (2016).
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Physical Rehabilitation - products
Physical Rehabilitation - accessories
Prosthetics & Orthotics - Orfitrans
Radiation Oncology - Thermoplastic materials
- Raycast® High Precision Efficast® Masks, Nanor Masks and Hybrid Masks with Nanor for Head, Neck and Shoulders
- Raycast® High Precision Efficast® Masks, Nanor Masks and Hybrid Masks with Nanor for Other Hardware
- Raycast® High Precision Masks for Extracranial Immobilization
- Raycast® Uon and Duon Masks
- Raycast® High Precision Thermoplastic Bolus Material
Radiation Oncology - Hardware & Accessories
- Vacuum pumps
- Vacuum Bag Cushions
- Thermofit
- The AIO Solution
- SRS Fix and Bite Fix
- SBRT
- Sagittilt™ Prone Breast Solution
- Raycast® Uon and Duon Base Plate
- Raycast® High Precision Positioning Lung Board Solution
- Raycast® High Precision Positioning aids for arms and shoulders
- Raycast® High Precision Patient Support Cushions
- Raycast® High Precision Orfit Extremities Solution
- Raycast® High Precision Base Plate-To-Couch Fixation Devices
- Raycast® High Precision Base Plates
- Raycast® High Precision Accessories Head Supports regular density
- Raycast® High Precision Accessories Head Supports regular density for push-pin hardware
- Raycast® High Precision Accessories Head Supports regular density extra soft for Cyberknife (for other hardware
- Raycast® High Precision Accessories Head Supports Low Density
- Raycast® High Precision Accessories Blocks and Wedges High Density
- Raycast® High Precision Accessories Head Supports Prone Head Supports
- MRI-S Solution
- MRI-S Solution for Head, Neck & Shoulders
- MRI-P Solution for Head and Neck
- MRI-G Solution for Head and Neck
- Moldcare
- MammoRX®
- Integra™
- HP PRO Solution
- Dry Heat Convection Oven
- Convection oven
- Aerial® Couchtop for Proton Therapy