Medical devices and in vitro diagnostic tests must have a CE Mark before you can place them on the European (including UK) market. This includes digital health products and Apps, if they meet the definition of a medical device.
We are experts in regulatory compliance with the new Medical Device (EU 2017/745) and In vitro Diagnostics Regulations (EU 2017/746) which came into force in May 2017 as well as the outgoing Medical Devices and in vitro Diagnostics Directives 93/42/EC and 98/79/EC .
We are very ‘hands-on’ offering practical and direct support to CE Mark your product through all stages of the product life cycle from R&D through to placing your device on the market and beyond:
We provide consultancy on
- Gap analysis and planning for your transition to the new Regulations
- Harmonising regulatory compliance requirements with your product development programme
- Securing your CE Mark by
- Device classification & conformity assessment
- Compilation of Technical Documentation
- Meeting the requirements for Clinical Evaluation
- Developing & implementing Quality Management Systems
- Preparing regulatory information to support grant funding bids
We deliver training on specific subjects , tailored to meet your particular needs. Subjects include-
- The MDR & IVDR- at an introductory or a detailed level
- The process of CE Marking a medical device
- Risk Management for medical devices per En ISO 14971:2012- Medical devices -Application of risk management to medical devices
- Clinical Evaluation-per MEDDEV 2.7/1 rev4
- Software development- per BS EN 62304:2006+A1:2015
Medical device software. Software life-cycle processes
- Post Market Surveillance
We can help you fulfil your obligations to have a Suitably Qualified Person in Regulatory Affairs to manage your QARA activities until you are ready to employ into a full-time position.
So, if you are unclear about your regulatory obligations, why not drop us a line for a free consultation.
Full details on our Contact page