ISO 13485-compatible gravity flow rack systems for medical device assembly, sterile component staging, and regulated material handling — designed to support design history file documentation, cleaning validation, and cGMP production requirements for Class II and III device manufacturers.
Every medical device flow rack is supplied with design documentation formatted for inclusion in the Design History File (DHF) and Device Master Record (DMR). Documents include material specifications, design drawings, risk assessment input, and change control records.
Rack frame and lane materials are non-particle-generating, non-shedding, and compatible with sterile pouch and blister pack handling. Surfaces do not puncture, abrade, or contaminate sterile primary packaging during normal rack operation.
Material declarations for all frame and lane components are supplied in a format compatible with ISO 10993 biocompatibility risk assessment documentation for medical devices where indirect material contact is a regulatory concern.
Medical device racks combine ISO cleanroom material requirements with cGMP design principles — no dead legs, no particle-trapping geometries, and full wipe-down accessibility — supporting simultaneous ISO 13485 and cGMP operating environments.
Lane-level RFID and barcode scanning supports lot and serial number traceability at every component pick, feeding CAPA and non-conformance systems with the container-level data required for medical device regulatory response.
Lane label holders and scanner mounts support UDI (Unique Device Identifier) scanning at the pick point, confirming the correct device component is consumed at each production step and recording the UDI in the MES for MDR reporting.
Anodized aluminum or 316L SS; per cleanroom class
Design documentation for DHF and DMR inclusion
Cleanroom-compatible; electropolished SS option
Non-abrasive lane contact; no puncture risk
ISO 10993 material declaration package available
RFID/barcode scan point; lot and UDI records
ISO 7–8 standard; ISO 5–6 by engineering review
Up to 800kg distributed per bay
ISO 13485; cGMP 21 CFR Part 820; EU MDR compatible
Component supply and sub-assembly staging racks for FDA Class II medical device assembly lines subject to 21 CFR Part 820 QSR and ISO 13485.
Precision component staging racks for implantable device assembly where biocompatibility documentation and contamination control are critical regulatory requirements.
Sterile pouch and tray component supply racks adjacent to medical device packaging lines where sterile barrier integrity must be maintained through the staging process.
Component flow racks for IVD reagent and consumable assembly lines operating under ISO 13485 and 21 CFR Part 820 dual regulatory requirements.
Modular Solutions supplies a medical device documentation package including material specifications and certifications, design drawings formatted for DHF inclusion, risk assessment input (FMEA contribution for rack-related failure modes), change control procedure for post-delivery modifications, and cleaning validation support data. All documents are revision-controlled and available in electronic format compatible with major eQMS platforms.
Yes. The rack design documentation is structured to support DHF inclusion as a production equipment record. This includes the design input (customer requirements), design output (drawings and specifications), design verification (material certs and finish records), and design transfer (installation and IQ records). Modular Solutions can provide a design review summary formatted for DHF inclusion if required.
Barcode scanner mounts at each lane front rail allow UDI scanning of the container label at each pick event. The scan data is sent to the MES, creating a production record that ties the UDI of the component container to the work order consuming it. This supports MDR adverse event reporting by providing the complete consumption history of any specific UDI-labeled component lot.
Yes. Under 21 CFR Part 820.70, production equipment that can cause product quality issues must be controlled. Flow racks that present components for assembly are within scope. Modular Solutions provides an IQ/OQ protocol template and supports the customer validation team through the execution and documentation of the Installation Qualification and Operational Qualification.
Standard anodized aluminum medical device racks with ISO 13485 documentation packages ship in three to five weeks from design approval. Electropolished 316L stainless steel versions require five to eight weeks. Custom cleanroom-certified builds with full biocompatibility documentation packages are quoted on a project basis with a lead time determined by the documentation review cycle.
Share your ISO 13485 documentation requirements, cleanroom class, sterile packaging constraints, and traceability system — we will design a rack system with a complete regulatory documentation package.
Request a Quote