European Medical Device Regulation (EU-MDR) has been saved
European Medical Device Regulation (EU-MDR)
EU-MDR and CE marking requires dedicated and specialised regulatory knowledge and practical experience
We provide a wide range of strategic and hands-on quality and regulatory support services in Device Lifecycle Support, Quality and Regulatory Automation and Training.
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The process of obtaining CE marking for medical devices can be long and complex. There is no one-size-fits-all-solution for the implementation of the medical device regulations. Endless variations exist between device types, manufacturers and supply chain process interactions.
Dedicated regulatory knowledge and practical experience are essential to overcome the regulatory hurdles faced by manufacturers and to design and implement the best possible solution for a device and the applicable lifecycle processes.
We assist manufacturers of medical devices with a wide range of quality and regulatory (Q&R) support services throughout the entire device lifecycle.
We have the right expertise for defining optimal strategies for placing and maintaining medical devices on the EU market.
We are specialised in Quality and Regulatory Compliance for Medical Devices in particular Regulation (EU) 2017/745 (EU-MDR). We assist manufacturers and other economic operators through compliance readiness and maturity assessments and by delivering compliance remediation and transformation projects.
Our global network accelerates the delivery of our Q&R services world-wide.
We provide a wide range of strategic and hands-on quality and regulatory (Q&R) support services in three main areas:
Device lifecycle support
From regulatory strategy development to product realisation, market authorisation & registration and post-market surveillance:
- Design controls & risk management
- Clinical evaluation & investigation
- Supplier controls & contract development
- Labelling & Instructions for use (IFU)
- Technical documentation (TD) setup & assessment
- Quality management system (QMS) setup & assessment
- Computer system validation (CSV)
- Unique device identification (UDI) & EUDAMED registration
- Post-market surveillance (PMS) & vigilance
Quality and Regulatory Automation
To automate regulatory intelligence, improve quality and regulatory information management and to speed regulatory submissions.
More and more they are considering technology-enabled solutions to fulfil the increased quality and regulatory demands. We support them in the selection, implementation and optimisation of the right information management solutions such as Regulatory Information Management Systems (RIMS) and electronic Quality Management Systems (eQMS).
To establish appropriate understanding of EU-MDR, the impact and benefits for all levels within your organisation, and to leverage best practice solutions seen in the industry.
Our focus areas
We assist the medical device industry with delivering regulatory compliance and transformation projects covering a wide range of medical device types such as:
- Digital / Connected / software Medical Devices
- Combination Products (including Drug-Device Combinations – DDCs)
- Implantable Medical Devices
- Substance-based Medical Devices
Besides medical devices, we also support the industry with their In vitro diagnostics, including companion diagnostics.
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European Medical Device Regulation
The complexity of qualification and classification