ISO 13485 Certification - Medical Devices

ISO 13485 is the international standard for quality management systems for those who produce and / or distribute medical devices. The assessment of quality management systems for medical devices focuses attention on the design, production and distribution of devices and the service offered to the customer, laying down more severe requirements that ensure greater control of processes.

The implementation of a quality management system has the positive effect of defining efficient and controlled processes and workflows, together with the recognition of an international certification, especially when it is combined with the marking of its products. If the CE marking of the products is required, CSI can offer an integrated certification service (system and product) by working in collaboration with the parent company of the group to which it belongs, which is notified for the Medical Devices Directive, acting as the only interlocutor. for the customer.

Since the ISO13485 standard contains the requirements of the ISO 9001 standard, it is possible to manage both certifications in an integrated way.

The ISO 13485 certification issued by CSI will allow to:

Communicate your quality standards
Gain a competitive advantage through independent certification
Benefit from the benefits of our long-standing laboratory experience
Use the recognition of a Notified Body (IMQ) for the certification of your medical devices

Examination of the application and documentation sent by the Company, listed in the "Special rules" specific to the product to be certified. Any deficiencies and significant deviations from the requirements, found at this stage, will be communicated so that the appropriate changes can be introduced before the assessment visit is carried out. Upon request, CSI will appoint an inspector to visit the organisation to verify the conformity of the product, process or service. If the results of the visit include non-conformities or observations, a corrective action plan will be required to meet the requirements for the issue of the product certificate. After all the non-conformities that may have emerged from the assessment visit have been passed, and after the positive outcome of the laboratory tests, certification will be granted. The issue of the certificate will be followed by surveillance visits to verify that compliance is being maintained. The frequency of surveillance visits and laboratory tests, if any, is fixed by the special rules applicable. The certification shall have the validity defined in the specific special rules, on expiry the contract shall be deemed to be tacitly renewed unless terminated by one of the two contracting parties 4 (four) months before the expiry date. Tool to certify, though an official recognized third-party body endorsement, that the company is compliant to the requirement... Tool to certify the capability of an organization to gain and maintain steadily, service standard declared to the public... Formal act of a third-party body that certify the conformity of the product technical reference documents, marketing deed to enhance and diversify the product... For years the training offered by IMQ group represented a point of reference for professional development and the update of freelance and employees. Second and third-party, inspections and testing: expert auditors capable to understand the situation of the company...