Absolute Imaging Solutions (AIS) has received its ISO 13485 Certificate of Registration from the NSF-ISR, which assesses conformance for the Sale, Repair, Refurbishment, Installation, and Servicing of ionizing and non-ionizing medical imaging devices.
ISO 13485 certification represents a formal accreditation to a set of standards from the International Organization for Standardization (ISO) describing requirements for the management system of medical device companies. ISO 13485 aims to facilitate a framework that aligns with the requirements of regulation agencies in the health care industry while maintaining a focus on customer satisfaction. This standard provides an international umbrella under which companies from different countries can comply.
The philosophy of ISO 13485 focuses on customer safety. It specifies requirements that touch processes related to product design, manufacturing and distribution. Emphasis on risk management and process maintenance ensures that the probability of injury has been reduced to the minimum. It asks that the developer anticipate all possible scenarios that would impact the patient negatively. Documentation identifying and managing risk management must be present throughout the life cycle of the product. ISO 14971, the companion set of standards, lists the detailed requirements of good risk management.
AIS is an ISO-9001 registered company, a Registered US Federal Contractor, and holds certifications from IAMERS and DOTmed.