FIAB management is strongly focused on the application and development of internal Quality System, in order to keep it efficient and effective in getting regulatory requirements and customer needings.. In particular, FIAB commitment is turned to:

ensure high quality of goods and services provided to the Customer;
ensure that Customer`s requirements are defined and satisfied during all stages of the contract, and that the products supplied to Customer are fully in accordance with the intended use;
assure that the requirements of the technical standards and regulations in force regarding medical devices are strictly updated and satisfied for any Country or geographical area where the devices are expected to be marketed;
communicate the organization the importance of meeting those requirements;
determine the interrelation of personnel who manage, perform and verify work affecting quality, ensuring that responsibilities and authorities are defined, documented and disseminated, and ensure the independence to carry out such activities, encouraging staff to actively co-operate to implement the Quality System and be proactive in suggesting improvements;
ensure that targets concernings processes and the relevant levels and functions of the company are achievable and measurable, and verify that these targets are met through the Planning for Quality;
assure that the resources made available – including human resources – are suitable quantitatively and qualitatively for the maintenance of the Quality System, to pursue the expected Objectives, to ensure the implementation of the activities planned, and that the internal communication should assure the efficacy of the Quality System processes;
conduct periodic reviews of quality management and monitor the implementation and effectiveness of quality plans;
ensure that evaluation of the experience gained from medical devices in the post-production phase is aimed at improving the devices.
implement and maintain a risk management approach in the processes of the Quality System and in the life cycle of products.

These objectives are pursued through quality standards and operational procedures clearly defined in the Quality Manual, and strictly enforced throughout the company and the production of the full range of FIAB medical devices. The Quality System procedures have been introduced in order to obtain attitudes within the company operating at the highest level in terms of quality.

These procedures are in accordance with the requirements of EN ISO 13485 and are the minimum standard adopted by FIAB. All Quality System procedures are mandatory and are not allowed unauthorized deviations from them. Procedures other than those laid down, or otherwise required by the customer, may apply only after that their effectiveness has been aptly demonstrated and management has agreed.

The Products are manufactured in accordance with the applicable European regulations (CE) on medical devices and meet the requirements of harmonized standards that apply to them. Regulatory requirements set by the Countries under MDSAP scheme are also applied: Australian ATGMDR 2002, Brazilian ANVISA RDC, Canadian CMDR, Japanese MHLW Ordinance no.169, U.S. FDA CFR Title 21 Part 820.

Cardiac Rhythm Management - Product Catalog