Training
Why training?
Regulatory requirements have been constantly changing. Medical device industry professionals must be able to understand and properly implement the requirements so that compliance is maintained.
Meliora Compliance provides training in several areas enabling the implementation and maintenance of efficient QMS, as well as successful placement of medical devices on the world markets.
We will design the training in the manner so that it best suits your organization, while taking into consideration the following:
- Size of your company
- Your product portfolio and current product lifecycle phase
- Status of your QMS
- Scope of your core activities (manufacturing, design and development, distribution)
- Current skills and experience, as well as the needs of your team members
- Your business goals
The scope of our training services includes the following regulatory requirements:
- CE marking per EU MDR and IVDR
- Clearances and approvals per US FDA requirements
- Implementation and maintenance of QMS per ISO 13485
- Implementation and maintenance of QMS per US FDA QSR (21 CFR Part 820)
- Regulatory aspects of clinical investigations
- Regulatory aspects of design and development
- MDSAP
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