Certification. Validation. Traceability.
For over twenty years we have ensured that our management system and our products comply with the demanding regulatory requirements in medical technology. The first certification according to ISO 9001 was already obtained at the beginning of the 90s. If you are interested in finding out more about our certifications and our management of standards as well as other quality topics, then you have come to the right place!
Do you have questions on these topics or do you require additional information? Do not hesitate to contact us.
Due to our diversified certifications and our standards management we are always abreast of state-of-the-art technology. This allows to adjust quickly to new technologies and procedures in our projects and makes us a reliable partner for our customers.
Audits are permanent companions in our line of business. Internal audits serve to check our processes for compliance and to improve them continuously. On the basis of risk classification, we also audit our suppliers regularly and can thus ensure that our network of partners continues to develop and improve. In the same vein, we are audited annually by various approved bodies. These confirm their findings in appropriate certificates which you are welcome to view in our Download Center.
Process validation serves documented proof and ensures that a process permanently meets the previously defined requirements and thus leads to reproducible results. It is an essential and important part in the manufacturing of medical devices and must be based on a process-based risk analysis.
Cendres+Métaux has considerable experience in the process validation for medical devices and can offer customers individual advice and support in specific questions. If possible, we also apply our validated equipment and processes to customer products. This needs to be checked carefully when providing a feasibility assessment. If the scope of our standard validations is not sufficient, we can either conduct special process validations for the manufacturing of your products or coordinate this together with competent partners.
Project management supported by a wide range of skills and comprehensive, competent advice - this is what distinguishes us. Interdisciplinary project work is guaranteed by the close cooperation between sales, production, development, technical project managers and quality management and is a given for us. This allows us to advise you in the preparation of your product documentation and provide you with important input on the topics of risk management and technical documentation:
Our aim is to ensure that our customers and partners and their ideas and projects feel well served and understood by our company. To build up this relationship of understanding requires an open exchange of information on behalf of both parties. Therefore, a contractually agreed protection of mutually exchanged information is essential as it forms the basis for a functioning and trustworthy partnership. We therefore view it as an important part of our daily work to establish and/or conclude confidentiality and quality agreements.