ISO 13485 – Medical devices – Quality Management Systems – Requirements for regulatory purposes
Scope of the Standard: ISO 13485 specifies requirements for a Quality Management System that can be used by an organization involved in the business of medical devices (one or more stages of their life-cycle).
Recipients of our consulting services: any organization willing to demonstrate its ability to provide medical devices and related services compliant to both customers’ needs and the applicable regulation requirements, such as Regulation (EU) 2017/745, as well as to penetrate reference markets.
Aim: the decision to be compliant to this Standard is a strategic choice. Having a Quality Management System compliant to ISO 13485 requirements allows producers of medical devices to demonstrate their ability to supply medical devices/services compliant to the a.m. Standard, local regulations and any eventual customers’ requirements (be they or not part of the organization) in a very concrete way. In order to ensure greater effectiveness of the Quality Management System, we strongly suggest the use of some additional joint standards (non-exhaustive list):
- ISO 14971 – Medical devices – Application of Risk Management to medical devices
- ISO 15223 – Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
- ISO 20417 – Medical devices – Information to be supplied by the manufacturer
By constantly monitoring legislative compliance of business processes and promoting their improvement and effectiveness, we can help organizations to increase customers’ and stakeholders’ confidence in the medical devices placed on the market.
Some of our services (non-exhaustive list):
- Initial meeting with the customer: analysis of the existing operating processes
- Definition of the best path to take, defined in accordance with the customer’s needs and expectations, products provided, etc., in order to adapt the existing Management System to the requirements of this Standard
- Training of the personnel involved
- Support during the control phase
- Planning of the periodic monitoring audit
Some of the advantages deriving from the implementation of a Quality Management System compliant to ISO 13485:
- The third-party certification of the a.m. Management System will be a clear proof of compliance with the applicable requirements, which will thus allow to provide quality services and devices
- The opportunity to distinguish themselves from other medical devices producers that do not have this certification
- High and certifiable traceability of medical devices during all phases of their existence (from the design phase to their final disposal)
- Higher level of compliance with this Standard will lead to a greater national/international corporate recognition, better processes and enhanced business
- Better qualitative results will positively impact on the degree of participation and involvement of the staff in the activities carried out, as well as trust by users of the offered devices
