Healthcare Development-Atemitech Corporation

Healthcare Development

With ISO 13485 certification in hand, Atemitech Technology ensures smooth client audits for medical equipment.

When integrating a new supplier, medical device brands often face a months-long qualification review by their QA teams. This process involves verifying certification documents, conducting process audits, and connecting design change control processes, each requiring the supplier to provide auditable documentation. Partnering with an ISO 13485 certified company with a complete quality control document infrastructure allows the process to move forward from initial contact without getting stalled by back-and-forth document amendments.

Product Requirements

ISO 13485 Medical Device Quality Management
Battery Safety Standards (IEC 62133, etc.)
Low Electromagnetic Interference Design (EMC/EMI)
Touch Display Supports Glove and Wet Hand Operation

Process Checkpoints

Supplier QA Audits and Certification Reviews
Design Change Control
Batch Tracking and Defect Record (CAPA)
Regulatory Affairs Confirmation (FDA/CE MDR)

How does Atemitech Technology's ISO 13485 certification practically aid in the QA audit processes for medical equipment clients?

Atemitech Technology is ISO 13485 certified and possesses a process document system that meets medical device quality management standards. This allows client QA teams to directly integrate with Atemitech's existing quality records and control framework, significantly reducing the time required for supplier qualification reviews.

Medical devices have strict requirements for battery safety and batch tracking; how does Atemitech Technology meet these demands?

Atemitech Technology's customized battery modules can be designed in accordance with medical equipment safety standards, with BMS for overcharge and over-discharge protection and safety circuits. Each batch of batteries comes with complete tracking records to meet CAPA process documentation requirements for defective product management.

Does the clinical environment have special requirements for the operating interface, and can Atemitech Technology's monitors accommodate this?

Atemitech Technology's industrial monitors support glove touch and wet hand operation, with a low reflection design suitable for clinical scenarios requiring high reliability human-machine interfaces, such as operating rooms and intensive care units. These can be customized according to equipment integration needs.

According to customer needs, we provide color temperature adjustment and Gamma correction; meanwhile, the monitor calibration complies with the DICOM Part 14 grayscale standard display function (GSDF), and with ISO 13485 production and design certification.

How does Atemitech Technology assist medical equipment customers in managing the design change risks from prototyping to mass production?

Atemitech Technology's prototype development and mass production are undertaken by the same team, allowing design changes to be synchronized internally in real time without cross-factory coordination. Process documents and design change records are maintained according to Design Control specifications and can be directly provided to the customer's regulatory affairs team for review.

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