Support for transitioning from IVDD to IVDR
Compared to the IVDD, the IVDR has introduced new requirements for all types of IVD products, for quality management systems of manufacturers, for all organizations within the supply chain, and even for hospital laboratories.
Many manufacturers will find themselves confronted with significant gaps in their product documentations and quality management systems, as well as that they will face inspection by a notified body for the first time. Distributors and importers might find themselves in a need of a quality management system, and hospital laboratories will need to identify their so called in-house IVD's for determining gaps in the documentation for those.
Regardless of your role within the IVD industry, Plantvision can help you on your IVDR journey.
In addition to the services listed below, we offer specific support for companies transitioning to IVDR. For starters, we can help your organization to gain a good understanding of the new regulation and its requirements. This can be achieved through introductory workshops, where we help you to identify your company's specific needs. Alternatively, you can look out for our Plantvision Academy.
We can also help you to efficiently define your transition plan by carrying out a thorough IVDR gap analysis, providing a detailed follow-up report with recommendations for what actions should be taken. Our consultants have broad industry experience, as well as in-depth knowledge about IVD's. We can help with risk, quality and regulatory management.
Through both strategy and resources we can help smooth the path to a CE marked product - from requirements, development, documentation and tests, to contacts with Notified bodies and market access. You can also ensure continuous support through our Compliance Partner service, which provides fast and efficient access to experienced consultants.
How can we support you?
- Compliance Partner
- Get regulatory support when YOU need it
- Gain access to a diverse team of regulatory experts
- Get help with regulatory questions or regulatory tasks
- We provide long-term partnerships that adapt to your needs
Quality Management System
Bring your QMS in line with EN ISO13485 and/or FDA requirements
We can help you design a new QMS, conduct QMS audits, or carry out QMS gap analyses against IVDR
We offer both defined QMS projects and QMS consultants
Technical Documentation
Update or create new documentation according to IVD
We provide gap analyses, action lists, documentation planning and report writing
We offer customized project packages, as well as project leaders and extra resource consultants
Performance Evaluation
We can provide verification & validation leads as well as support resources for...
- Compiling PE plans and reports
- Systematic literature reviews and writing of scientific validity reports
- Planning and performing analytical performance studies
- Evaluation of clinical data and planning scope of clinical studies
