MEDICAL DEVICE REGULATORY SERVICES

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:

CONSULTANCY

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

TRAINING

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

INTERIM MANAGEMENT

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