Medical Device Regulatory Services
UKCA for medical devices and IVDs, MDR Regulation 2017/745
Manufacturers of medical devices must traverse a complicated set of regulatory mandates in order to sell their products abroad. EOMI Consultancy provides robust quality management solutions to address this challenge, including assistance with the creation and Implementation of ISO 13485 Quality Management systems and Technical file creation and review.
EOMI Consultancy offer specialised EU MDR & UKCA medical device regulation consultancy to those companies who want to comply and gain access into the market for any kind of medical device.
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Services Include:
- Gap analysis of Quality Management System and Technical file
- Identification of applicable standards
- Classification of medical devices and IVD's
- Risk Management
- Clinical Evaluation Reports
- Technical documentation preparation and management, including General Safety and Performance Requirements (GSPR)
- Instructions for Use (IFU) and labelling updates/review
- Creation of a Unique Device Identification (UDI) system including Basic UDI-DI
- Post Market Surveillance Support
- Registration Activities