TECHNICAL DOCUMENTATION
WE ARE EXPERIENCED COMPILERS OF TECHNICAL DOCUMENTATION
MDS compiles and maintains the technical documentation of your company’s medical device. The technical documentation must be compiled when you apply for the CE marking, and maintenance is mandatory to retain the CE marking. Our consultants take care of all areas of technical documentation.
Areas of technical documentation:
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definition of customer requirements
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definition of technical requirements
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risk analysis
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usability assessment
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documentation of the verification work
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validations
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clinical evaluation
WE TAKE CARE OF YOUR COMPANY’S MDR/IVDR UPDATES IN AN EFFICIENT MANNER
Outsource your company’s MDR/IVDR updates to us. We take care of the technical documentation and the necessary updates to your quality management system. The regulatory environment is changing rapidly, and the demands for manufacturers, distributors and importers are increasing.
Our team always uses the latest information to update your quality management system and technical documentation. We also share our competence to our clients through training.
In the EU, the most significant changes for medical devices are related to the implementation of the MD and IVD regulations. The transitional period is still ongoing, but the system updates should be considered in advance so that you have time to complete the changes in time.
WE HAVE THE COMPETENCE TO CARRY OUT CLINICAL EVALUATIONS
We write dozens of clinical evaluations and evaluation plans annually. The evaluation focuses on a literary review that examines the scientific background of the company’s products and related products as well as existing clinical evidence and potentially identified risks.
With the help of the literary review, we assess the safety and efficiency of the examined product in the intended purpose of use.
WHAT DO WE DO BESIDES TECHNICAL DOCUMENTATION?
Our multi-competent consultancy team can assist you with various matters, such as FDA approvals, usability and electrical safety tests. Among our best-selling services are the building and commissioning of electronic documentation systems, the building of complete quality management systems, and providing continuous quality management maintenance as an external QA Manager.
We can also supply different types of statements for statutory interpretation of various pieces of legislation.
We also produce documentation, such as PSUR, SSED and SSCP.
