Yes, subject to project qualification. We manufacture to customer-approved drawings and material specifications and can retain defined material and production records. The customer is responsible for identifying applicable regulations, approving the final material and product design, arranging required third-party testing, and confirming final-market compliance.
We process a range of engineering thermoplastics and filled grades, which may include PA, PC, PBT, POM, PPS, PEEK, LCP and PPO/PPE families. Capability must be confirmed for the exact supplier grade, filler content, color, annual volume, part geometry and performance requirements. Your engineering team retains final material approval.
Expected mold life is defined project by project. We consider the approved resin, filler content, mold steel and hardness, cavity design, surface finish, cycle conditions, production location and preventive-maintenance plan. The quotation should state the expected service scope, maintenance responsibility, wear exclusions and warranty terms.
Please provide 3D CAD, a 2D drawing, resin grade, part weight, annual volume and critical requirements. We evaluate projected area, estimated cavity pressure, shot size, mold dimensions, tie-bar spacing, clamp force, handling and inspection access before confirming machine compatibility.
Yes, subject to review of the exact resin grade. UL 94 classifications apply to specified material records and recognized conditions such as thickness and color. We can retain supplier material documentation when required, while final component and end-product compliance remains the customer's responsibility.
Documentation is defined in the approved quality plan and may include first-article inspection, dimensional reports, material certificates or lot records, process parameters, SPC data for agreed CTQs, appearance standards and shipment inspection records. Please identify mandatory documents in the RFQ.
Sterilization compatibility cannot be determined from a polymer name alone. We review the exact resin manufacturer and grade against supplier data for the proposed EtO, gamma, electron-beam, steam, or other process. The device manufacturer must validate the actual dose or cycle, aging, packaging, dimensions, function, residues, and biological safety of the final device.
ABERY’s quality management system is currently certified to ISO 9001:2015, not ISO 13485:2016. ABERY is not presented on this page as an FDA-registered medical-device manufacturer. We can provide the supplier and manufacturing records agreed for the project so the legal manufacturer can evaluate ABERY within its supplier-control process. Required audit scope, documents, retention, access, and corrective-action expectations must be reviewed before quotation.
The FDA Quality Management System Regulation became effective on 2 February 2026 and amended 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. Website and audit language should therefore use the current QMSR terminology.
ABERY does not operate a certified cleanroom. For approved work in our general manufacturing environment, the agreed controls may include material and tool identification, storage segregation, equipment and hopper cleaning, documented purge, restrictions on regrind and additives, approved cleaning agents and lubricants, line clearance, protected handling, packaging, and release inspection. The customer must determine whether these controls are suitable for the component’s intended use.
We can support customer-defined validation activities when the protocol, equipment, process, samples, acceptance criteria, statistical methods, deviations, records, responsibilities, and approval route are agreed in advance. Available data may include machine setup and process parameters, inspection results, material lots, production samples, and statistical results. Cavity-pressure data is available only when suitable sensors and acquisition equipment are included in the project.
Protocol ownership, execution, report approval, revalidation triggers, and final process release must be defined in a responsibility matrix.
