What We Do?

The experts at the Cdaqi stay up-to-date with the latest regulations and standards, to provide Customers with the most relevant and reliable medical device guidance. Cdaqi offer expertise and advice on localised medical device regulations during the approval of products, at every stage of their development.
When introducing a new product to the market, Customers can choose to oversee the relevant regulatory requirements or hand responsibility to CMO.
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Regulatory:
New Medical Devices Regulation now published
- On April 5, 2017 the EU adopted the new Medical Devices Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive. The new regulation will enter into force after a three-year transition period ending in spring 2020.
- This means that the market access framework for all member countries of the European single market will change significantly.
- Medical Device & Diagnostics Regulatory Affairs
- Regulatory strategy development and pathways to market
- Consultancy services and support throughout the product life cycle
- Device classification determination, intended use statement development and predicate device determination
- Pre-market, post-approval and post-market support
- Appraisal and evaluation of technical documentation
- Preliminary assessments, gap analyses and desktop audits
- Technical files, design dossiers and quality system support
- European authorized representation services and UK responsible person services
- Notified Body discussions and pre-submission FDA meetings
EU MDR
- The EU Medical Device Regulation was designed to protect the fitness and safety of European Union residents. It officially replaced the Medical Device Directive (MDD) in May 2021, with the aim of enhancing safety for European patients through a more robust and transparent framework. It brings medical devices regulation in line with technical advances, changes in medical science and progress in law making.
- The requirements for MDR are more robust than MDD, and MDR covers a greater range of products. Once the transition period has elapsed, all applicable products must comply with MDR.

Key Changes
Notified Bodies |
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Clinical evidence |
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Pre-market |
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Post-market surveillance and vigilance |
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Transparency and traceability |
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Governance and oversight |
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