Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | In vitro diagnostic manufacturers |
| Work | Technical documentation and quality-system planning |
| Rules and standards | European IVDR conformity assessment and CE marking preparation |
HMC supports preparation of technical documentation and quality system work for in vitro diagnostic devices under the European In Vitro Diagnostic Medical Devices Regulation (IVDR).
● Strategically convert from IVDD to IVDR
● Identify the list that needs to be prioritized for consideration
● Update technical documents in accordance with regulations
● Setting up a quality management system and navigation
Service information adapted from the original source ↗.
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