Quality and compliance with standards are of the utmost importance In the field of medical technology – for the safety and reliability of the products for both users and patients. To ensure that your products and their specifications fulfill the applicable requirements, Bertrandt can support you with services relating to all aspects of quality management throughout the entire product life cycle, from the initial idea to series production.
Medical products are subject to a wide variety of standards and requirements, each of which requires different documentation to ensure full traceability and monitoring. Some FDA requirements relating to QM systems are regulated in 21CFR820. For these and other regulations, our QM experts will support you in establishing quality standards, as well as in complying with all requirements for your medical devices – to make sure that you are on the safe side with your processes and products. We will also be happy to support you in a supplier audit.
Examples of our services in Quality Management:
- Creation and implementation of a 13485-based QM system
- Gap analyses
- Support in the processing of quality issues
- Creation and negotiation of quality management agreements for suppliers
- Implementation of supplier audits
- Training courses on quality topics
- Development of an e-learning system