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The path to successful product certification in medical technology
Insight in Brief
Our team of experts accompanies you from product development to submission to regulatory authorities and offers comprehensive consulting in the area of quality management systems. Even after approval, we remain your partner for market surveillance and certificate maintenance to ensure your market entry is efficient and successful.
1. Consulting in the field of quality management systems
Definition of the standards and laws to be complied with for the quality management system.
2. Establishment of your QMS
Creation of a Quality Management System including execution of the internal audit and possible mock audits in preparation for certification.
3. Consulting in the area of product development
Among other things, the definition of the standards and laws to be complied with for the product's intended use and/or indications for use, specification, usability, verification, and validation as well as the approval strategy.
4. Support for verification & validation
In particular, pre-compliance testing in our test lab, standards testing in our lab or in accredited partner companies, and certification in a lab in our network.
5. Technical documentation
Development of technical documentation respectively DHF/DMR/DHR according to the requirements of the target market.
6. Submission
Support in submitting the technical documentation to regulatory authorities, notified bodies, or certification organizations in order to be allowed to place the medical device on the respective market.
7. Market surveillance and maintenance
Support in monitoring the device on the market as well as maintaining certifications and approvals, processing of findings from authorities, notified bodies, customer audits, etc.
Summary
Our informative expert blog guides you step-by-step through the challenging path of product certification in medical technology. It highlights all important aspects and stages of the process, from initial product development to continuous market surveillance after successful certification. With our in-depth knowledge and many years of experience, we want to support you in successfully mastering the challenges on the path to product certification.
If you need customized support in all areas of product certification in medical technology, please contact our experts - We look forward to accompanying you on your way to success.
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